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by Mark Blumenthal and Katherine Purcell
On July 18, the United States Senate confirmed the appointment of Lester M. Crawford, DVM, PhD, as the new Commissioner of the Food and Drug Administration (FDA). The vote in the Senate was 78 for and 16 against.
Dr. Crawford has been serving as Acting Commissioner since the appointment of former FDA Commissioner Mark B. McClellan MD, PhD, to head the federal Centers for Medicare and Medicaid Services in March 2004 and had served in this capacity prior to Dr. McClellan’s appointment. Dr. Crawford also served as FDA’s Deputy Commissioner under Dr. McClellan. In February 2005 President Bush nominated him to run the agency.
According to the biography of Dr. Crawford on the FDA website (http://www.fda.gov/oc/crawford/bio.html), Dr. Crawford has previously served as the Chair of the Department of Physiology-Pharmacology at the University of Georgia, Administrator of the Food Safety and Inspection Service at the U.S. Department of Agriculture as well as the Deputy Commissioner of FDA, as already noted. From 1997-2002, he was Director of the Center for Food and Nutrition Policy at Georgetown University and at Virginia Tech, where it moved in 2001. The FDA bio says that he has played “major roles” in mandatory nutrition labeling, the formation of the World Trade Organization and the control of chemical and microbiological contaminants of food, and has been an advisor to the World Health Organization of the United Nations for much of his career. Dr. Crawford received his Doctor of Veterinary Medicine (DVM) from Auburn University, his PhD in pharmacology from the University of Georgia, and his Honorary Doctorate (MDV) from Budapest University.
Throughout much of the Bush administration, the FDA has not had a Commissioner. This has led to numerous concerns in Congress and elsewhere that the Agency was not being managed as effectively as possible, especially with respect to dealing with drug safety, full regulation of DS, etc. Dr. Crawford’s appointment had been stalled recently due to various political issues. Among these were concerns by various Senators over the mounting safety problems related to the FDA’s system for the approval of new drugs, particularly in the wake of the recall of Vioxx® and other COX-2 inhibiting drugs. Another political issue related to the FDA’s possible approval of the Plan B birth control pill also affected his nomination. One vocal critic was Republican Sen. Charles Grassley of Iowa, who, according to a Reuter’s article, said, “During Doctor Crawford’s tenure, I have witnessed the suppression of the scientific process and the muzzling of scientific dissent.” 1 Two Democrats, Sen. Hillary Clinton (D-NY) and Sen. Patty Murray (D-WA), had previously placed holds on Dr. Crawford’s nomination to demand that FDA agree to finalize its decision on over-the-counter availability of the controversial birth control pill. Other issues included the concerns of one Senator, Sen. Tom Coburn (R-OK), that that FDA has not adequately enforced condom labeling. These holds by these senators were dropped during the few days prior to the confirmation, and, after another last-minute and short-lived objection by freshman Senator, Sen. David Vitter (R-LA) initiated a new hold on July 18, the vote by the full Senate was scheduled.
Responses to Confirmation
Secretary of Health and Human Services Mike Leavitt was supportive of Dr. Crawford’s nomination. In a press release he said, “Dr. Crawford is a dedicated public servant who has ably led the agency [FDA] over the last year and previously served as Deputy Commissioner. The FDA has a critical role in protecting the nation’s food supply and ensuring the safety of the medicines we take based on the best science available. I look forward to working with Dr. Crawford and FDA as we seek to continue advancing the nation’s health.”2
Commissioner Crawford received support from Senate leaders from both political parties. Sen. Orrin Hatch (R-UT), a leading champion of the dietary supplement industry, said in a press release, “Dr. Crawford is a demonstrated leader, someone with a strong knowledge of science and an unwavering commitment to promoting and protecting the public health. He will be an outstanding commissioner.”3
Sen. Edward Kennedy (D-MA) said, “As a scientist, he recognizes that science is nothing if it lacks integrity. He understands that science loses its power to heal, to inform, to improve lives if the facts are ignored at the whim of politics. He continued, “I support his confirmation, and I look forward to working with him in the years ahead.”4
Various consumer groups have expressed mixed opinions on the Crawford confirmation. Michael F. Jacobson, the executive director of The Center for Science in the Public Interest (CSPI), offered his opinion in a statement on the center’s Web site: “The FDA is an agency in crisis, especially on the drug side. We hope that Lester Crawford will be able to rise above corporate pressures and the Administration’s anti-regulatory agenda to make consumers’ health his paramount concern.” He continued, “An effective FDA could save hundreds of thousands of lives by promoting better medical practices and improving the nutritional quality of the food supply. Dr. Crawford’s past service in government and in industry raises questions about his appropriateness to lead the beleaguered agency, but we will wish him much success and seek to work with him if he is confirmed as commissioner,” Jacobson said.5
In general, industry spokespersons have strongly supported Dr .Crawford’s previous record of increasing FDA’s enforcement of provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA), and his position that DSHEA provides adequate safeguards for the effective monitoring of DS quality, safety and benefits.
Loren Israelsen, director of the Utah Natural Products Alliance, a Utah-based group representing over 50 large manufacturers and processors of herbs and DS, stated in an email, “This should be regarded as good news for the DS industry. Dr. Crawford has, over the years, demonstrated a willingness and a practicality to work together with our industry to resolve DS-related issues. As recently as 10 days ago, I had a meeting with him and found his demeanor, perspectives and comments helpful. We should now hope for a renewed effort by FDA to seek conclusion of open issues relative to dietary supplements such as GMP regulations, other related quality standards and a more focused enforcement and compliance program.”6
Michael McGuffin, president of the American Herbal Products Association (AHPA), the leading herb industry trade association, said, “The confirmation of Dr. Crawford as FDA Commissioner should be seen as good news by responsible marketers of dietary supplements. This industry continues to ask for full implementation and active enforcement of DSHEA and its implementing regulations, and we are more likely to see progress now. I have worked with Dr. Crawford over the past several years and look forward to working with him further.”7
Steve Mister, president of the Council for Responsible Nutrition, a leading trade group of DS manufacturers, said in an email, “As both deputy commissioner and acting commissioner, Dr. Crawford has been extremely active in regulating dietary supplements by implementing the Dietary Supplement Health and Education Act (DSHEA). By using the authority provided by DSHEA, Dr. Crawford has sent a strong message to all supplement companies that they must comply with the law or face the consequences. Further, the dietary supplement industry has been impressed by Dr. Crawford’s openness in dealing with industry, thereby proving that regulatory success is best achieved by forming partnerships with key stakeholders, including government, regulatory agencies, industry and others. CRN is pleased that Dr. Crawford’s appointment has been supported by the U.S. Senate and looks forward to working with him in his new capacity to further implement DSHEA.”8
“It is great to see someone with such depth of experience confirmed as FDA commissioner,” said David Seckman, executive director and CEO of the National Nutritional Foods Association in a press release. “As acting commissioner, Dr. Crawford proved tough but fair, and we look forward to working with him.”9
References
1 Heavey S. UPDATE 2-U.S. Senate approves Bush's pick to head FDA. Reuters.com. July 18, 2005. Available at: http://today.reuters.com/news/newsArticleSearch.aspx?storyID=17339+19-Jul-2005+RTRS&srch=%22Charles+Grassley%22+. Accessed: July 29, 2005.
2. HHS Press Office. Statement by Mike Leavitt Secretary of Health and Human Services Regarding Senate Confirmation of New FDA Commissioner.[press release]. Washington, D.C: U.S. Department of Health & Human Services; July 18, 2005. Available at: http://www.hhs.gov/news/press/2005pres/20050718.html. Accessed Jul 27, 2005.
3. Anon. Hatch: Crawford has vision to lead FDA through crucial period. [press release]. Washington, DC: Washington DC Office of US Senator Orrin Hatch; July 18, 2005. Available at: http://hatch.senate.gov/index.cfm?FuseAction=PressReleases.View&PressRelease_id=1389. Accessed Jul 27, 2005.
4. Kennedy E. Statement by Senator Edward M. Kennedy on nomination of Lester Crawford [Press Release].Washington, DC: Office of Senator Edward M. Kennedy of Massachusetts; June 15, 2005. Available at: http://kennedy.senate.gov/index_low.html. Accessed: July 28, 2005.
5. Jacobson M. CSPI Reacts to Lester Crawford Nomination. [press release].Washington, DC: Center for Science in the Public Interest; February 14, 2005. Available at: http://www.cspinet.org/new/200502142.html. Accessed Jul 28, 2005.
6. Anon. Lester Crawford. LDI e-News Update. Salt Lake City, UT: LDI Group, Jul 19, 2005.
7. Anon. Senate Confirms Crawford as FDA Commissioner.[press release]. Silver Spring, MD: American Herbal Products Association; Jul 19, 2005.
8. Anon. CRN applauds confirmation of Dr. Crawford as new FDA Commissioner. [press release]. Washington, DC: Council for Responsible Nutrition, Jul 19, 2005.
9. Anon. Crawford confirmed as FDA commissioner. NNFA Update, Jul 20, 2005.
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