Democratic control of the White House, Senate and House brings the potential of a "more aggressive" FDA into sharp focus.

Many people agree FDA needs leadership that will respond more rapidly to safety concerns and communicate more clearly with the public and legislators. But some potential candidates may make stakeholders nervous (see chart: " ¹ Who Will Obama Appoint To Lead FDA? ").

Industry critics Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, and Baltimore Commissioner of Health Joshua Sharfstein are among the names being floated as possible FDA candidates.

Chris Schott, a biotechnology and pharmaceuticals analyst with J.P. Morgan, said during a Nov. 5 conference call that the idea of Nissen taking FDA's reins "scares us a lot."

Regardless of whether drug or supplement companies find it scary, they should be aware of the "significant change in the national government" brought about by the presidential and congressional elections, American Herbal Products Association President Michael McGuffin observed.

"There will always be concern that when you have a Democratic executive and a Democratic legislature, when you have one party controlling both, there's a greater need to ensure our vigilance," McGuffin said in an interview.

Who Succeeds Von Eschenbach?

Nissen, a past chairman of FDA's Cardiovascular and Renal Drugs Advisory Committee, in 2007 co-authored a meta-analysis that drew attention to the potential cardiovascular risk associated with GlaxoSmithKline's type 2 diabetes drug Avandia (rosiglitazone). He also has questioned the safety of COX-2 inhibitors.

In 2006, Nissen testified to the Senate Health, Education, Labor and Pensions Committee on the need for greater agency oversight of dietary supplements, including a mandatory adverse events reporting system (² Also see "Cleveland Clinic’s Nissen Asks HELP Panel For Stronger Supplement Regulation" - Pink Sheet, 20 November, 2006., p. 4).

In addition to questioning the safety and efficacy of some supplements, Nissen told the committee that some consumers use dietary supplements when they need prescription medication.

Sharfstein was mentioned as a "dark horse" candidate for FDA commissioner in a J.P. Morgan health care policy report.

And because Sharfstein previously served as a health care policy staffer under Rep. Henry Waxman, D-Calif., the chances for his nomination will improve significantly in the drug industry's view if Waxman wrests the Energy and Commerce Committee chair from Rep. John Dingell of Michigan.

Although he is an activist, pharma stakeholders acknowledge Sharfstein has the experience and training to lead FDA.

Sharfstein initially made waves by taking the lead on a 2007 citizen's petition asking FDA to review the safety and efficacy of OTC pediatric cough/cold products (³ Also see "FDA Review Of Children’s Cough/Cold OTCs Has Broader Implications" - Pink Sheet, 5 March, 2007., p. 3).

He continues pressing for voluntary industry withdrawal of the products for children up to age 6 following the latest industry response to those concerns - a labeling change to "do not use" in children up to age 4 (⁴ Also see "Firms Consult FDA, Add “Do Not Use” For Under 4 To Pediatric Cold Products" - Pink Sheet, 13 October, 2008., p. 4).

One potential nominee, FDA Center of Drug Evaluation and Research Director Janet Woodcock, most likely would have more industry support than Nissen or Sharfstein.

While playing key roles at CDER and in other offices in tightening FDA's enforcement policies, Woodcock is considered a leading agency authority on drug safety and efficacy.

Further, after working at FDA since 1986, including as a deputy commissioner and chief medical officer, Woodcock is seen to have executive experience rather than working with an activist agenda.

Another possible candidate for the FDA post is Susan Wood, former head of women's health at FDA who resigned in protest over the handling of the OTC switch of Barr's Plan B morning-after pill (⁵ Also see "NDAC’s Wood Departs FDA Committee; Joins Private Investment Firm" - Pink Sheet, 8 May, 2006., p. 3).

Food and drug attorney John Manthei, a former House Committee on Energy and Commerce majority counsel, cautioned that a clear enemy of the drug industry is not likely to be appointed.

"In the role FDA has with the industry, they're obviously the regulator, but they also need a degree of collaboration," Manthei said during a Nov. 5 conference call hosted by law firm Latham & Watkins, where he is a partner and global co-chairman of the Health Care and Life Sciences Practice.

"If you put somebody in that position who for the lack of a better way to describe it, has a hostility toward the industry or a mistrust toward industry, I think that would be a setup for a not very successful individual steering FDA in what really is a difficult time," he added.

The Consumer Healthcare Products Association did not offer particular candidates it would support for the post, but said the "next FDA commissioner must have the substantive experience and leadership skills to retool the agency for the 21st century and ensure the public trust."

Among its criteria for "ideal candidates," CHPA includes responding to FDA's "expanding scope by securing additional funding, maintaining an expert workforce, and modernizing IT systems."

The trade group also recommends that Obama look for an FDA leader with "an ability to fully transition the agency from a domestic to a global perspective."

Who Influences Obama?

The question of who in Congress might have particular influence on Obama's choices for FDA commissioner and chief counsel remains up in the air. Senate HELP Committee Chairman Ted Kennedy, D-Mass., has traditionally held sway over these picks, but he is currently battling cancer.

Manthei said it is not clear whether Kennedy's stance against FDA commissioners coming directly from industry will remain in play.

"It will be interesting to see if that selection criterion will still hold" since it "obviously is going to eliminate a number of very qualified applicants," he added.

Should Kennedy's influence fade, Manthei and others see a potential expanded role for Sen. Dick Durbin in advising Obama on health care-related areas.

Given Durbin's long-standing advocacy of enhancing regulation of herbal and nutritional products, the supplement industry will keep an eye on the Illinois Democrat (see ⁶ Also see "Bigger Stage Expected For Durbin’s Supplement Industry Criticism" - Pink Sheet, 10 November, 2008. ).

New York Sen. Hillary Clinton's role in congressional drug and health care actions should grow, possibly with some influence on Obama's FDA choice, Manthei said.

"She's obviously very well-respected, smart and brings a tremendous amount of experience and expertise on health issues. I think most people would expect her to emerge as a new key player on Senate FDA issues as well as Senate health issues," he said.

What Happens At FDA?

With bigger majorities in both chambers of Congress, Manthei said Democrats' preference for more pre-market regulation and post-market enforcement of food and drug products will be imposed on FDA.

"I think we should fully expect to see a much more aggressive FDA as we move into 2009," he said.

However, FDA is not likely to bear the brunt of congressional ire about problems with drug safety or with access to health care.

While Republican administration appointees were targets of members of the opposing majority in the House and Senate, Democrats during the 111th Congress will not apply as much scrutiny to the performance of Obama's appointments.

Democrats' lighter touch with Obama appointees will be clear at FDA, where Dingell, Waxman and other key majority members have made oversight a priority.

"That obviously is an intensely political environment and certainly I think oversight of FDA is going to come to an immediate halt in January of 2009," Manthei said.

"I don't think you should look for the Hill to drag up Obama political appointees to answer for what are viewed as inadequacies in the FDA process."

Instead, the pharmaceutical industry should be ready to "be in congressional oversight crosshairs," Manthei added.

Drug firms "kind of fell in a comfort zone" of five-year intervals between passage of major legislation imposing significant regulatory changes on the industry.

"Those days are over and I think industry should fully expect and be prepared that FDA legislation can become an annual event," he said.

J.P. Morgan's Schott said he expects "a more functional FDA" with Democrats in the White House and controlling Congress.

"I think one of the challenges in my group over the last couple of years has been what appears to be shifting and somewhat inconsistent standards at the agency when it comes to drug approval. Some level of reform at the FDA I think at least could give us more predictable requirements," he said.

"They might be more conservative, they might be broader, but if they're predictable that's something certainly my industry could deal with."

Where Are Industry Opportunities?

Asking more of the food and drug industry could bring not only more or increased regulation, but also more opportunities for businesses.

McGuffin said Obama's campaign comments about health care reform include a clear incentive for herbal and nutritional product companies.

Like longtime supplement industry ally Sen. Tom Harkin, D-Iowa, Obama has said the U.S. needs to change from a "disease care system" to health care, McGuffin said.

Being part of health care reform from the ground up is an opportunity that the supplement industry can create under the Obama administration and Democratic Congress.

The opportunity begins with extending health care reform beyond "insurance reform," McGuffin observed.

"Is there an opportunity in a truly open conversation about establishing a health care system to replace a disease care system? Can the best of our products, can some of the well-established alternative practitioners insert themselves more meaningfully in the U.S. health care system?"

"I'm willing to see that an opportunity might exist and that we'll have to be smart enough to figure out how to get in the room and make the opportunity," he added.

During the J.P. Morgan conference call, Dan Elling, Republican staff director for the Ways and Means Subcommittee on Health, said he does not expect Congress to support allowing health savings accounts to cover purchases of vitamins and supplements.

"I think until you have some sort of greater regulatory responsibilities at FDA over those types of products, I don't know that that's all too realistic," Elling said.

He added that he has questioned supplement industry proposals to have herbal and nutritional products covered by insurance programs.

"One of the things that I always said when one of the companies came in was, 'Well, you say that you do all of these things, but if you look at a box of Cheerios they say that it lowers your cholesterol and improves other things. Are we supposed to allow that to be a deductible health care cost as well?'"

"So I'm not sure how you get there, at least not yet." Elling added.

- Malcolm Spicer (m.spicer@elsevier.com), Dan Schiff (d.schiff@elsevier.com) and Katie Stevenson (k.stevenson@elsevier.com)

With Democrat In White House, “More Aggressive” FDA Comes Into Focus

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