◊ MEMBERS ONLY ◊ SITE MAP ◊ CONTACT

◊ 

 

 Government and Public Affairs 
   Bulletin Archive - 2001

Bulletin No. 12, December 18, 2001

NIGMS Pharmacogenetics Research Network 

The NIGMS Pharmacogenetics Research Network has chosen the journal Pharmacological Reviews to partner with the Network in publishing summaries of data submissions to the Pharmacogenetics knowledge Base (PharmGKB).  In June 2001, the Network sought proposals for the journal partnership by issuing a letter of invitation to interested journals. By establishing the partnership, the Network wants to develop standard print format reports that will help alert the scientific community to the availability of new pharmacogenetic data sets. 

The Pharmacogenetics Research Network determined that Pharmacological Reviews best met the criteria of: readership and impact factor; free, full-text access to journal content; journal longevity; and whether the publisher is mission or profit-driven. The Editor in Chief of Pharmacological Reviews (published by ASPET) is Darrell Abernethy, M.D., Ph.D. 

 PharmGKB data sets are expected to be published online in Pharmacological Reviews in early  2002. 

USP Announces Launch of Dietary Supplement Verification Program 

The United States Pharmacopeial Convention (USP) is announcing the availability of its Dietary Supplement Verification Program.  Based on USP's assessment of the manufacturer's capability to produce a dietary supplement and testing to USP standards, USP will issue a certification mark that can be used by the manufacturer on the dietary supplement container label.  The presence of this mark on a dietary supplement product container is an indication to the practitioner, consumer, retailer, and other interested parties that the product contains the dietary supplement ingredient in the designated amount, meets acceptable limits of undesirable elements, and is manufactured appropriately. 

USP is named in the Dietary Supplement Health and Education Act amendments (DSHEA) to the Federal Food, Drug and Cosmetic Act as the nation's official compendium for dietary supplement standards.  USP will work with participating manufacturers in the coming months to conduct rigorous assessments that will allow the use of the verification mark.  The program includes: laboratory evaluation of product samples and regular monitoring; evaluation of manufacturer's quality systems by means of an audit; and quality control and manufacturing data review. 

The DSVP Program does not address structure/function claims that were created under DSHEA. The USP Council of Experts' (CoE) Dietary Supplement Expert Committee will initially review all products submitted for verification where safety concerns have been raised. 

Commission Suggests Regulations and Incentives Could Spur Research on Supplements 

The White House Commission on Complementary and Alternative Medicine suggested at a recent meeting that one way to quickly spur research on dietary supplements is to provide intellectual property protections and patent laws that encourage research in this field.  The rationale is that if the government is going to regulate dietary supplements as drugs it should give them similar incentives.  Industry has in the past been reluctant to the idea believing that such changes would not be effective.  Industry maintains that it would be difficult to protect claims on dietary supplements the way claims protect new drugs because supplements are already in wide use.  If a company finds a new use for Vitamin C and gains exclusive rights to a health claim, consumers would know that other Vitamin C products have the same benefit.  If a supplement existed that was not sold on the market a company can put the supplement through the new drug approval process.  Presumably Congress could amend DSHEA for such legislation but there is strong opposition by industry and among some key lawmakers to revisit DSHEA. 


Bulletin No. 11, November 12, 2001

Research Community Focuses on Bioterror and Impact on Research  

ASPET is seeking members with expertise in various facets of chemical, biological, nuclear, and neurobiological warfare. ASPET would like to develop a list of individuals that could be recommended to organizations (see below) and news organizations that are helping develop recommendations to policy makers. Contact Jim Bernstein at Jbernstein@aspet.org. 

The AAAS is sponsoring a symposium that will look at how research priorities are certain to be affected by the war on terrorism.  The Bush Administration and Congress are also considering national security measures aimed at protecting citizens and vital national interests. While many of these measures are necessary, it is essential that the scientific community be engaged in evaluating them and their impacts on the environment for research, as well as carefully considering their own professional and personal roles in this very dynamic and highly charged political environment.  Speakers will include White House Science Advisor John Marburger and

National Academy of Engineering President William Wulf. This one-day symposium (no-charge) will be held in the AAAS auditorium on December 18.  You may register on-line now at: http:/www.aaas.org/spp/scifree/terrorism/regis.htm 

The National Academy of Sciences is also holding two upcoming meetings on the subject: 

November 27-28: "Biological Threats and Terrorism: How prepared are we?  Assessing the science and our response capabilities".  Includes scientific sessions on biological agents: anthrax, smallpox, and other toxins; barriers and opportunities to countering large-scale disease outbreaks; control and early detection measures; and the coordinated response and preparedness of the public health system. 

December 14:  working title of the symposium is "September 11: Implications for the Research University."  This symposium came out of a discussion hosted by the Science, Technology, and Law Program.  The theme of the symposium will be trying to assess the implications of the terrorist attacks for the research community.  Three aspects of research universities will be examined and the impact of terrorism assessed: (1) access to scientific information and materials, (2) the flow and tracking of students, scholars and faculty, and (3) the nature of research programs.  Following the workshop, working groups will be established to analyze these issues in more depth.

If you have interest AND expertise in these areas and would like to participate in the meetings, please send me your name and contact information and we will forward your recommendations to FASEB.  FASEB will be coordinating names of qualified individuals with the NAS.

Senate Passes HHS Spending Bill, Conference Awaits 

The Senate passed its version of the FY 2002 Labor/HHS Appropriations bill providing NIH $23.695 billion, a $3.4 billion or 16.8% increase over FY 2001 and $820 million more than the House bill.  The conference committee to reconcile the differences between the House and Senate versions is expected to begin this week. 

Some Disaster Relief AIDS Animal Rights Organizations 

The American Physiological Society has posted to its website an article designed to inform readers that some of the animal rights organizations that receive contributions from the United Way and Combined Federal Campaign take positions against animal-based research.  The APS urges those who contribute to the CFC and UW make informed decisions about designating their contributions to specific charities. The article, "Are You Giving Money to Undermine Medical Research?" may be found at: http://www.the-aps.org/pub_affairs/leg_act_cntr/news/money.htm.


Bulletin No. 10, October 17, 2001

Senate Proposes $3.4 Billion, House $2.6 Billion Increase for NIH  
ASPET Report Language Included in House Committee Report  

On October 11, the full House and Senate Appropriations Subcommittee passed their respective FY 2002 Labor-HHS-Education appropriations bills. The House bill appropriation of $22.875 billion for the NIH, an increase of $2.58 billion or 12.7%. The Senate Committee version provides $23.7 billion for the NIH, a $3.4 billion or 16.7% increase.

The $800 million difference between the House and Senate means that conferees will have to reconcile the difference.  Congress must work within a $686 billion total discretionary budget to meet the Senate figure for the NIH. 

Included in the House Committee Report that accompanies the bill is language written and supported by ASPET that encourages increased research on botanicals within NIH’s National Center for Complementary and Alternative Medicine:  

“Herbal Medicine- The Committee encourages the Center to enhance research to study the basic mechanisms of action and toxicity of herbal medicine through all available mechanisms, as appropriate, including requests for applications. The Committee also encourages the Center to enhance research on the risk of unanticipated and potentially dangerous interactions between botanical and prescription drugs and to continue to seek collaboration with other Institutes on research opportunities on botanical drugs that could lead to the development of new therapeutics.” 

Also included is report language on NCI dealing with natural products drug development:

“The Committee encourages NCI to enhance the Natural Products Drug Development program, particularly in the area of complementary and alternative medicine. Recent surveys indicate that a majority of cancer patients will include complementary and alternative therapies in their treatment regime. NCI is encouraged to support high quality research proposals investigating cancer therapies such as iscadore and other botanical substances. Ayurvedic, homeopathic, traditional Chinese approaches, and alternative dietary approaches. The Director of the Institute should be prepared to provide a progress report at the fiscal year 2003 appropriations hearings.”

ASPET Supports Dietary Supplement, Ephedrine Legislation 

Rep. Susan Davis (D-CA) has introduced the Dietary Supplement Information Act (H.R. 3065) and the Ephedrine Alkaloid Consumer Protection Act (H.R. 3066).  ASPET has endorsed both bills joining other signatories that include the: American Academy of Pediatrics, Neal Benowitz, M.D.- University of California, San Francisco, Bill Gurley, Ph.D - University of Arkansas for Medical Sciences, Christine Haller, M.D. - University of California, San Francisco, Allen Solomon, M.D.- Georgetown University Medical Center, American Association of Family and Consumer Sciences, American Cancer Society, American College of Clinical Pharmacology, American Heart Association, American Institute for Cancer Research, American Public Health Association, American Society for Clinical Pharmacology & Therapeutics, Association of American Medical Colleges, Center for Science in the Public Interest, National Consumers League, and the  Society for Nutrition Education.

The Dietary Supplement Information Act would mandate that manufacturers, producers and distributors of dietary supplements would be required to register with the Food and Drug Administration.  Manufacturers will also be required to register their specific products with the FDA.  The supplement industry will be required to submit all serious adverse event reports to the FDA within 15 days.   

The Ephedrine Alkaloid Consumer Protection Act intends to give consumers information about the potentially lethal side effects and drug interactions of ephedrine alkaloid products.  The legislation requires a standardized warning to be printed on the label.  The bill would prohibit the sale of ephedrine to minors under the age of 18 years old.  

Antiterrorism Legislation Could Restrict Access to Biological Agents, Changes to Student Visa Program

Legislation being drafted by the House and Senate Judiciary Committees may tighten restrictions on biological agents, requiring HHS to ensure all research and public health laboratories and manufacturing facilities that possess certain hazardous microorganisms and toxins meet regulatory standards.  Certain antibioterrorism measures could result in additional burdens on legitimate biological research, in spite of the need for increased research on vaccines, biological sensors, new treatments and other areas as a way to improve the nation's response to a terrorist biological attack.

Senator Diane Feinstein (D-CA) also was considering introducing legislation that would reform the U.S. student visa program.  Feinstein’s bill would impose a temporary six-month moratorium on the student visa program.  This moratorium would give the INS time to fully develop its foreign student tracking system and to put into place the necessary infrastructure to detect foreign students who have violated the terms of their visas once they have entered the U.S.  At press time, Feinstein was reconsidering the moratorium after meeting with representatives of colleges and universities.   

Federal Vaccine Manufacturing for Bioterrorism Products an Option

 The congressionally created Gilmore Commission (Gov. James Gilmore, R-VA) that proposed the creation of the National Homeland Security Agency recommends that the new agency’s primary responsibility be in setting research priorities for federal agencies, including the Department of Health and Human Services and to facilitate the research and development of vaccines along with other non-medical products to combat terror attacks.  The commission recommended that HHS develop a specific comprehensive strategy for the health and medical fields and called for the establishment of a National Advisory Board for Health and Medicine.

The USP-NF Becomes a Yearly Publication
Online Book Tour Highlights First Annual Edition


The U.S. Pharmacopeia (USP) has announced that its official standards publication, the United States Pharmacopeia and the National Formulary (USP-NF) will now be published annually with two Supplements. The current edition, USP 24-NF 19, has been official since January 2000. The new annual edition, USP 25-NF 20, which will be available in November 2001, becomes official in January 2002 and will be followed by Supplements in February and June-becoming official in April and August 2002.  An online book tour, available at www.usp.org, will provide interested ASPET members a quick informational overview of the USP-NF.


Bulletin No. 9, September 26, 2001

War Footing Refocuses Spending Priorities 

Congress’ annual end game run on federal spending priorities is usually nearing the finish line this time of year and is characteristically marked by partisan fighting.  But those plans and behavior were put on hold since the terrorist attacks on New York and Washington.  Immediately and days after the attacks, all appropriations matters, as well as scheduled hearings on stem cells, human subject protections, and other policy matters, have been suspended.  Lawmakers unified response to the attack pushes partisanship into hibernation.   

All past debate on spending the social security “surplus” is over.  A $40 billion emergency supplemental and future spending on the war effort will mean that the money will have to come from somewhere.   The non-human element of the tragedy means that all other domestic discretionary spending programs, like the NIH, will have to wait and see what happens next.  But no one really knows how recent events will effect future spending.  Will lawmakers be able to concede spending gains on their favored programs?  Some details are now just beginning to emerge and it seems likely that most programs, including the NIH, will get what was specified in the President’s budget resolution for FY’02.  For NIH, that would mean an increase of $2.8 billion above last years figure.  

There had been talk that Congressional leadership may postpone any action on the FY 2002 budget and pass open-ended “Continuing Resolutions”  (CR) that would keep the government funded programs operating at current levels beginning on the new fiscal year, which begins October 1. A two-week CR is being considered that would fund the government through October 15.  Congress would like to finish all 13 individual spending bills, but there is a good chance that some of them, including the Labor-HHS spending bill that funds NIH, will be rolled in some sort of omnibus spending bill.  One emerging contentious issue is whether the White House will support $4 billion additional education spending without seeking $4 billion in cuts from other spending.  If the President insists on these offsets, settlement of spending bills once again becomes a problem.  

Improved Public Health Surveillance and Readiness Needed for Biowarfare  

One week before the terrorists’ attacks, Senate Foreign Relations Committee Chair Joe Biden (D-DE) held the first of several planned hearings on bioterrorism threats and the U.S. readiness to respond.  Former CIA Director James Woolsey and former Sen. Sam Nunn (D-GA) said the country is unprepared for bio-terror attacks.  "We need to recognize the central role of public health and medicine in this effort and engage these professionals fully as partners on the national security team," Nunn said.  Nunn also recommended that stockpiles of pharmaceuticals and vaccines should be built up, intelligence gathering and surveillance be beefed up, and plans be made for the best use of hospital resources in light of mass casualties.   

According to the Dept. of Health and Human Services, anti-bioterrorism efforts will focus on improving the nation's public health surveillance network; strengthening local medical response capability; expanding pharmaceutical stockpiles; conducting more research on disease agents and vaccines and regulating shipment of hazardous biological agents.  President Bush’s budget proposed spending $1.75 billion for defense against weapons of mass destruction in FY’01.  This number will certainly be increased significantly. 

A White House report released to Congress prior to the attacks says the NIH is looking to build a government owned and commercially run facility to produce vaccines for bioterrorism attacks.  The Bush administration had asked for a $43 million increase in FY’02 spending for vaccines. 

A government owned facility was thought of as one way to overcome the private sectors reluctance to develop products with, what was believed to be the case before September 11, no market.   In its FY’02 budget, the NIAID proposed to fund basic and applied research of biological agents such as anthrax, plague, and smallpox.  NIAID has already issued four requests for applications to stimulate research in these areas. 

BIO (the Biotechnology Industry Organization) has been asked by HHS and FDA to communicate with biotech companies regarding concerns that their research, manufacturing or contract facilities become a source of biological agents that could be used by terrorists; and whether their company has in place procedures to raise an alert in the event of an unusual order of a product that could relate to terrorist activity.   

NIH Security Note 

ASPET members coming to Bethesda for NIH business should be aware that security at the campus has been tightened and could delay your scheduled time for arriving at a meeting.  The problem is particularly difficult during the morning rush hours with hundreds, thousands of cars entering the campus and being stopped at security checks.   


Bulletin No. 8, August 16, 2001

Stem Cell Research Advocates Plan Post-Recess Action 

Legislation to expand the federal government's role in funding human embryonic stem cell research may gain momentum once Members of Congress return from their August recess. The Senate Health, Education, Labor and Pensions Committee plans to hold a September 5 hearing to review proposals introduced by Sen. Bill Frist (R-TN) and one by Sen. Arlen Specter (R-PA).

The Chair of the Committee, Sen. Ted Kennedy (D-MA) is supportive of moving beyond the Bush proposal that limited work on existing stem cell lines.  However, the Committee’s ranking member, Judd Gregg (R-NH), said he supports more funding for studying adult stem cells and no funding to create or destroy human embryos.  

Specter hopes to pass a bill that would allow federal funding to extract stem cells from embryos that would otherwise be destroyed. Specter's bill would allow for federally funded research and require the National Institutes of Health to write guidelines.  

NAS Report on Trends in Federal Research Funding 

A National Academy of Sciences report on trends in federal research funding confirms what everyone knows: more money is going to biomedical sciences and less to physical science and engineering.  The findings show that: in 1999, 46% of all federal funding for research went to life sciences and 31% for physical sciences and engineering; over a period from 1993-1999, funding for physics, geology and electrical, mechanical, and chemical engineering dropped by 20% or more in real terms; but funding for astronautical engineering rose 80% and oceanography 47% in the same time frame.  In fields where there is less federal support now than in 1993, both graduate school enrollment and the number of students receiving PHD’s have declined.  The full report is available at http://www.nap.edu/books/0309075890/html/. 

Animal Rights Groups Asks Supporters for Tax Rebate      

PETA and the political action committee of the Humane Society of the United States are asking their supporters to sign over their tax rebate checks to the animal rights movement.  HSUS has asked that rebates be donated to Humane USA, "the nation's first major political action committee singularly devoted to the task of electing humane-minded candidates to federal and state office."

"At no other time in history have so many positive legislative actions been taken to improve the treatment of animals," the rebate appeal claims.  The letter, signed by Wayne Pacelle, Humane USA Chairman and Vice President for Government Relations of HSUS, says "Our financial

and campaign support for candidates is paying enormous dividends."  PETA is asking the public to "Put Your Tax Rebate Check to Work" and specifically to support its campaign against animal research by the U.S. Environmental Protection Agency.

Bulletin No. 7, July 16, 2001

NIH Draft on Stem Cells Supports Need for Animal Models of Human Disease 

A NIH report on human embryonic stem cells prepared for HHS Secretary Tommy Thompson in late June states that human stem cells should be transplanted into animal models of human disease, and animal transplantation models be used to help answer whether embryonic stem cells are more versatile than adult stem cells. The draft says trials of stem cells in humans cannot move ahead until the relationship between unregulated growth potential and stem cells is further evaluated. "It is essential that careful toxicology studies are performed that are of the appropriate duration and that involve transplantation into immunocompromised animals of undifferentiated or partially differentiated embryonic stem cells, as well as adult stem cells." 

President Bush is expected to make a decision sometime soon on whether to allow federal funding of embryonic stem cells move forward.  Bush is grappling with the moral, ethical, and political issues involved in allowing the research.  At issue in the controversy is the Clinton Administration's interpretation of the existing federal ban on embryo research as not applying to work with embryonic stem cells so long as the cells had been extracted with private funding. NIH was to begin review of grant applications for this research but HHS Secretary Tommy Thompson stopped it pending a review of the Clinton Administration interpretation. 

NIH Appropriations 

With the congressional appropriations process moving forward, bills that fund the NIH and NSF face big problems.  The Labor, HHS bill that funds NIH will in all likelihood not be marked up until September.  The problem for this bill is that despite having FY’02 $119.8 billion for discretionary programs (10 billion more allocated than in FY ’01) like the NIH, the Congressional Budget Office estimates that the Labor/HHS subcommittee actually would need $111.5 billion just to keep programs at a freeze level.  Add in the proposed record NIH increase, Bush’s education initiatives, additional funding for all other programs in the bill and the $119.8 billion allocation suddenly is not enough. 

In recent years, Congress has “found” money to pay for programs.  But this has happened with record budget surpluses that allowed Congress to be generous. Tax cuts and a slowing economy may show that these surpluses have moved closer into deficit territory.  

White House Panel Suggest More $$$ for DSHEA 

The White House Commission on Complementary and Alternative Medicine is expected to recommend increased funding for FDA that would allow for full implementation of the laws regulating dietary supplements.    The Commission is also considering ways to improve FDA’s adverse event reporting system and allowing incentives for supplement makers to apply for NDAs order to make health claims.  A final report by the Commission is expected in March 2002.  A draft has not been made public but is reportedly on its way to HHS secretary Tommy Thompson.  

New NCI Web Site For All NCI-Supported Research                                               

NCI has created a comprehensive, easy to use source of information about current NCI-supported research. The Cancer Research Portfolio http://researchportfolio.cancer.gov/ is a new NCI web site containing information on approximately 9000 research projects, including grants, contracts, and clinical trials active in Fiscal Year 2000. The site will allow research scientists to more easily identify scientists doing similar work, as well as contacts for multidisciplinary research and collaborations. 


Bulletin No. 6, June 29, 2001

PRAT Fellowships for Postdoctoral Scientists at the NIH

The Pharmacology Research Associate (PRAT) Program of the NIGMS sponsors postdoctoral fellows conducting research at the NIH in the pharmacological sciences.  This can include research in the areas of signal transduction, drug metabolism, immunopharmacology, chemistry and drug design, structural biology, endocrinology, neuroscience, clinical pharmacology, among other areas.  Potential fellows make an application together with a preceptor to the PRAT program.  Selected fellows receive a two-year appointment, salary, supplies and travel funds from the NIGMS to support research in the preceptors’ laboratories.  Candidates may apply prior to coming to NIH or FDA, or they may have started postdoctoral research at NIH or FDA within the 12-month period prior to the application receipt deadline.  Applications are due on or before January 3, 2002 for fellowships starting in October of that year.  Only U.S. citizens or permanent residents are eligible.  Contact the PRAT Program Assistant at 301-594-3583 or prat@nigms.nih.gov to request a PRAT fact sheet and an application kit or visit the NIGMS home page at http://www.nih.gov/nigms/about_nigms/prat.html to view the PRAT fact sheet.

Bush Decision on Stem Cells Imminent

A decision by the Bush Administration to allow federal funding of human embryonic stem cell research is expected soon and the issue has received widespread publicity among all national news sources.  There has been increased pressure from within Republican ranks calling for President Bush to change his campaign pledge opposing federal funding for research utilizing human embryonic stem cells and to instead allow the work to proceed.  The message from some conservative, traditionally pro-life Republicans is that supporting stem cell research is in fact a pro-life position. Sen. Orrin Hatch (R-UT) who once advocated a Constitutional amendment allowing Congress and the states to ban abortions, wrote letters to Bush and HHS Secretary Tommy Thompson urging them to allow the NIH to fund stem cell research.  "Mr. President, once you have considered all the complexities of the questions at hand, I hope you will conclude, as other pro-life, pro-family Republicans such as Strom Thurmond (R-SC), Gordon Smith (R-OR), Connie Mack (R-FL, retired), and I, that the best course of action is to lead the way for this vital research.”  Hatch, who until the recent Democratic take-over of the Senate chaired the Judiciary Committee, asserted "after reviewing the relevant statutes and regulations, I conclude that there is no mandatory legal barrier under federal law to federal funding of research on human pluripotent embryonic stem cells."

Early this year Bush held up NIH’s attempt to allow NIH grantees to work with stem cells derived from embryos even though they are prohibited by law from conducting research with the embryos themselves.  Bush said he wanted to review all the science and legal issues before making a final decision on whether NIH should proceed with funding the research.

Working Group Calls for Major NIH Initiative on Construction of Extramural Facilities

At the June 7 meeting of the Advisory Committee to the Director of NIH, a special working group called upon that agency and the federal government to substantially increase direct funding and other financial support for construction and renovation of extramural research facilities.  Among its many findings and proposals, the group urged Congress and NIH to increase funding to support federal grants for facilities construction and renovation, suggested the federal government create a loan guarantee program to assist institutions in securing lower interest rates on debt financed construction, and recommended that OMB Circular A-21 be modified to allow a partial reimbursement of the capital costs from monies contributed directly by institutions to construction costs.


Bulletin No. 5, May 15, 2001

NCCAM Explores New Opportunities for Future Collaboration with Industry

NIH’s National Center for Complementary and Alternative Medicine (NCCAM) held a colloquium on May 14, 2001, to explore opportunities to collaborate with industrial stakeholders that produce, label, and market dietary supplements and other biologically based treatments, and organizations that develop and apply standards to determine quality and safety of these products. The purpose of the meeting is to begin a dialogue on how NCCAM and industry can work together to definitively evaluate CAM therapeutic products for composition, safety, and efficacy, and to obtain input from the broad stakeholder community. Meeting planners announced that JAMA would provide a complete summary of the meeting in an upcoming publication.

Leaders from key federal government regulatory agencies, major industrial, non-profit, consumers, and researcher groups addressed important topics including: the role of NCCAM and the NIH Office of Dietary Supplements in studying CAM therapeutics within the context of the NIH mission, the scope of interests and needs of the CAM therapeutics industry in developing and marketing CAM therapeutics, which aspects of the existing NIH models for NIH-industry collaboration are relevant and which are not?, and do issues of intellectual property and proprietary reagents enter into the ability of the NIH to undertake or collaborate in studies of CAM therapeutics?

Sen. Harkin Opposes Amending DSHEA; States Seek Regulatory Guidance

Sen. Tom Harkin (D-IA), who wrote the 1994 Dietary Supplement Health and Education Act (DSHEA) that governs FDA regulation of dietary supplements, said that he is against amending the existing law.  Harkin stated at a policy conference that the legislation already provides adequate safety with the authority it gives FDA to pull unsafe supplements from the market.  Harkin admitted that FDA’s adverse event reporting system is broken but that this is not DSHEA’s fault.   FDA is currently reviewing the legislative history to see if the law allows the agency to implement mandatory adverse event reporting.   A HHS Office of the Inspector General report has called for mandatory adverse event reporting.

The Association of Food and Drug Officials (AFDO), an association of state regulatory officials, has been working with FDA to develop some understanding of how the agency interprets DSHEA.  Because FDA does not have resources to carry out inspections of food retail markets and restaurants, states assume much of this burden.  AFDO notes that states’ main focus is food not drugs but that they would like to be at least knowledgeable about DSHEA even if they can’t help with its implementation.  AFDO notes that dietary supplements are pharmacologically active drugs and provide more than nutrition, but they do not have expertise to begin to regulate these products.  Thus, some states are seeking regulatory guidance from FDA.

Animal Rights Coalition Hires Bob Dole

Lobbyist and former Senator Bob Dole reportedly has signed on with a coalition of animal-rights groups to promote coverage of rodents and birds under the Animal Welfare Act (AWA).
According to the May 11 issue of Science magazine, Dole signed a letter for advertising purposes for the Working Group to Preserve the AWA.  In that letter, Dole reportedly says that arguments claiming the AWA does not cover rodents are "preposterous…We certainly did not intend to exclude [from regulation] 95 percent of the animals used in biomedical research."  Dole helped write portions of the AWA while a U.S. Senator.

Stem Cell Review Meeting Canceled; Administration Review Continues

The NIH cancelled a scheduled April 25 meeting of the Human Pluripotent Stem Cell Review Group (HPSCRG).  NIH canceled the meeting due to the ongoing department review of the stem cell issue. During recent testimony before the Senate Labor/HHS & Education Appropriations Subcommittee, HHS Secretary Thompson said that the HHS General Counsel legal opinion that allowed the NIH to pursue stem cell research activities is currently under review.  He also indicated that NIH is in the process of "conducting a scientific review" of stem cell research.  According to the secretary, the legal review and the NIH scientific review will be submitted to him in early June.

Congress Debates NIH/CDC Funding Dilemma

Congressional appropriators are faced with their annual dilemma of which agency will pay for the NIH increase.  This issue has become more pronounced as NIH is enjoying the successful momentum of the five year to double the agency’s budget.  At odds with this bipartisan support for NIH is growing awareness that other federal agencies conducting important research will pay for NIH’s success.  President Bush has proposed that $164 million be cut from the Centers for Disease Control but that NIH receive a $2.8 billion increase.  Both agencies are funded by the same appropriations subcommittee.  Any attempt to restore funds to CDC would likely come from any increases to the NIH budget.  "My responsibility as chairman and as a member of this committee is to make the best judgment about the use of the resources that we have," House Labor/HHS Subcommittee Chair Ralph Regula (R-OH) noted. "We have difficult priority choices and CDC is obviously very important...These are decisions that the committee will have to make, and I'm not prepared to make a flat out statement as to how we will allocate resources."


 

Bulletin No. 4, April 30, 2001

NCCAM Explores New Opportunities for Future Collaboration with Industry 

NIH’s National Center for Complementary and Alternative Medicine (NCCAM) will hold a colloquium on May 14, 2001, to explore opportunities to collaborate with two key groups: Industrial stakeholders that produce, label, and market complementary and alternative medicine (CAM) therapeutics (e.g., dietary supplements and other biologically based treatments), and organizations that develop and apply standards to determine quality and safety of these products. The purpose of the meeting is to begin a dialogue on how NCCAM and industry can work together to definitively evaluate CAM therapeutic products for composition, safety, and efficacy, and to obtain input from the broad stakeholder
community. 

Senator Tom Harkin (D-IA), who spearheaded legislation to create NCCAM (formerly the Office of 
Alternative Medicine), will open the colloquium: Exploring Opportunities for Collaboration with Industry with an overview of NCCAM's legislative mandate. Stephen E. Straus, M.D., Director of NCCAM will discuss NCCAM's perspective with respect to opportunities to establish collaboration with industry. 

Leaders from key federal government regulatory agencies, major industrial, non-profit, consumers, and researcher groups will address important topics to include: (1) The role of NCCAM and the NIH Office of Dietary Supplements in studying CAM therapeutics within the context of the NIH mission, (2) The scope of interests and needs of the CAM therapeutics industry in developing and marketing CAM therapeutics, (3) Areas of interest common to NCCAM and the CAM therapeutics industry, (4) Areas of complementary expertise contributed by NCCAM and the CAM therapeutics industry, and (5) Regulatory authorities and responsibilities of other federal agencies. Additional information, including an agenda and featured speakers at this meeting is available at: http://www.nccam.nih.gov/nccam/colloquium

Stem Cell Review Meeting Canceled; Administration Review Continues 

The NIH cancelled a scheduled April 25 meeting of the Human Pluripotent Stem Cell Review Group (HPSCRG). NIH canceled the meeting due to the ongoing department review of the stem cell issue. During recent testimony before the Senate Labor/HHS & Education Appropriations Subcommittee, HHS Secretary Thompson said that the HHS General Counsel legal opinion that allowed the NIH to pursue stem cell research activities is currently under review. He also indicated that NIH is in the process of "conducting a scientific review" of stem cell research.   According to the secretary, the legal review and the NIH scientific review will be submitted to him in early June.


Bulletin No. 3, March 1, 2001

Bush Budget Proposes 13.8%, $2.8 Billion Increase For NIH 

President Bush’s FY 2002 budget proposal includes a $2.8 billion increase to $23.1 billion for the NIH. This would be a 13.8% increase over the FY 2001 appropriation of $20.3 billion. The president’s proposed increase would be the largest in percentage and real dollars in NIH history.  But it also falls short of Congressional efforts to double the NIH by 2003 (a 16.5% increase to $23.7 billion would be needed to remain on track for the doubling). Several days prior to his formal release of the budget to Congress, the President unveiled his budget priorities that included education and health care needs: “We recognize the federal government plays a very important role in researching cures for disease, and therefore, our budget increases the NIH budget for 2002 by $2.8 billion, the largest increase in that department's history." By almost any measure, the President’s proposal is remarkable and medical research advocates hope they can increase that amount to maintain the momentum towards the doubling effort. 

The budget proposal indicates the administration intends to save money in HHS with unspecified cuts to programs to help train health professionals, and the elimination of the $125 million Community Access Program, launched by the Clinton administration to try to better integrate the delivery of healthcare services. 

HHS Secretary Visits NIH, Encourages Applications For Stem Cell Grants 

The Bush Administration will decide this summer if it will allow federal funding of embryonic stem cell research. HHS Secretary Tommy Thompson visited the NIH campus February 28 and said that scientists are encouraged to submit stem cell research applications to meet the grant deadline of March 15. He indicated the decision would be made within the four months between the March 15 deadline and the time
awards are now scheduled to be made. 

An interpretation of the law by the Clinton Administration's HHS General Counsel's office has ruled a provision forbidding research on human embryos does not cover embryonic stem cell research because "such cells are not human embryos." 

Thompson also met with acting director Ruth Kirschstein and other institute directors to discuss what could be accomplished with the Bush Administration's first budget proposal for the agency. 

Thompson noted that one problem is how to keep researchers and physicians at NIH and how to attract bright young minds to science and medicine. Thompson indicated that he did not think the naming of a new “permanent director” would be done soon although it is a high priority.  He said the White House had two or three names and asked NIH directors to provide him with additional names for consideration. 


Bulletin No. 2, February 15, 2001

Bush Budget for NIH Due Soon? House Science Committee Chair Speaks on NIH 

President Bush is expected to submit his outline for the administration’s FY 2002 budget proposals in late-February but that might be delayed.  A more comprehensive budget will be unveiled, possibly in late March or April. Bush has stated he supported the doubling effort for the NIH and OMB officials are telling advocacy groups that this commitment is firm although no one will confirm numbers. Keep in mind that a large increase for the NIH proposed by the President will make NIH a big target for later cuts since any significant increase will come at the expense of other programs. 

House Science Committee Chairman Sherwood Boehlert (R-NY) said his committee would look into the balance between biomedical and other federal research funding and of the impact of growing links between research universities and industry. The Science Committee has no jurisdiction over NIH funding. Boehlert, speaking before the annual meeting of the Universities Research Association said that he would
continue to support increases in research funding, particularly for “physical sciences.” However, Boehlert said that while NIH increases the past few years "certainly gives one the feeling that things may be out of whack…given the public concern with health and the advances in biology, why shouldn't NIH get a larger share of the pie?" 

Boehlert also said "an honest, open look" at university-industry partnerships "should help make them more productive rather than hampering them." Rep. Boehlert's speech to the Universities Research Association is available online at http://www.house.gov/science/ura_013101.htm 

Specter Stays As Chair of Senate Labor/HHS and Education Subcommittee 

Senator Arlen Specter (R-PA), Chair of the Senate Appropriations Subcommittee on Labor, Health and Human Services and Education, announced that he would remain as chair of the Subcommittee. Specter last summer announced that he would resign his chair largely due to the frustration he felt over what has become annual dueling over priorities and growth of the spending bill. Specter is a strong supporter of the NIH and his previously announced “resignation” concerned the biomedical research community, particularly with the retirement of Specter’s House counterpart John Porter (R-IL), that NIH would be without its most effective congressional advocates. Specter cited the importance of “continuity” of efforts to help ensure the doubling of the NIH budget by FY 2003 and to help “liberate medical researchers from any restrictions on the use of discarded embryos to produce stem cells and discarded fetal tissue which are key to curing Parkinson's, Alzheimer's, spinal cord injuries, heart disease and, perhaps cancer and other diseases.” 

Also, Specter together with Senator Tom Harkin (D-IA) introduced a resolution (S. Res. 19) to express the Sense of the Senate that the funding for the NIH should be increased by $3.4 billion in FY 2002. Eleven other senators cosponsored the resolution. Both the Ad Hoc Group for Medical Research Funding and FASEB have proposed a $3.4 billion increase in the NIH budget as the fourth step in doubling the NIH budget by FY 2003. 

FASEB 

FASEB is planning to develop a high-profile publication to highlight research of the FASEB member societies involving animals. This publication would be disseminated to media and also to Voluntary Health Associations. 


Bulletin No. 1, January 16, 2001

FIRST DIRECTOR OF NEW NIH CENTER 

John Ruffin, Ph.D., was named the first Director of the newly established National Center on Minority Health and Health Disparities (NCMHD) at the National Institutes of Health. The new Center will conduct and support research, training, dissemination of information, and other programs about minority health conditions and about populations with health disparities. 

The specific goals and purposes of the new Center include the following: 

· To assist in the development of an integrated national health research agenda, across disciplines, that reflects the current and emerging health needs of racial and ethnic minorities and other health disparity groups. 

· To promote and facilitate the creation of a robust minority health research environment with sustained funding for a wide breadth of studies -- basic, clinical, and population research; studies on the influences of health processes; and research on the societal, cultural, and environmental dimensions of health -- all aimed at identifying potential risk factors for disparate health outcomes. 

· To promote, assist, and support research capacity building activities in the minority and medically-underserved communities, focusing on research infrastructure development, faculty career development, and increasing the number of underrepresented minority students and students
from health disparity groups with an interest in careers in biomedical and bio-behavioral research. 

Dr. Ruffin has over 25 years of experience in developing and administering innovative programs designed to train the next generation of minority scientists and improve the health of minority populations. He received his Baccalaureate Degree from Dillard University and Master's Degree from Atlanta University. He earned a Ph.D. at Kansas State University in Systematic and Developmental Biology, followed by Postdoctoral Studies at Harvard University. 

NIH Increases Training Stipends 

NIH will increase stipends for National Research Service awards (NRSA) to pre-doctoral and postdoctoral trainees. The new predoctoral stipend is $16,500; postdoctoral stipends range from $28,260-$44,412. The budgetary changes will take effect for NRSA Awards made with FY
2001 funds. 

New Labor-HHS Subcommittee Chair 

Rep. Ralph Regula (R-Ohio) succeeds retired Rep. John Edward Porter (R-Ill.) as the chair of the Labor, HHS, Education, and Related Agencies Subcommittee. The Subcommittee has jurisdiction for funding the NIH. Rep. Henry Bonilla (R-Texas) will chair the Agriculture Subcommittee, which has jurisdiction over FDA. 


Students  |  Members  |  Membership  |  Training Programs  |  Meetings  |  News  |  About Pharmacology  |  Publications  |  Divisions, Chapters, and Interest Groups  |  Awards and Fellowships  | Education Resources | Pharmacology Resources | Site Map  |  Contact

Copyright © 1997-2001 by the American Society for Pharmacology and Experimental Therapeutics.
last modified on 06/17/08