Loss Of Sen. Kennedy Leaves Hole In HELP Committee, FDA Oversight

The passing of Sen. Ted Kennedy deprives the Senate of one of its most prolific figures in the area of health legislation and leaves open the chairmanship of the committee with FDA oversight.

In addition to being now one vote short of the 60 needed to defeat a filibuster, Democrats must try to fill Kennedy's post at the helm of the Senate Health, Education, Labor and Pensions Committee.

Experts on health policy and on FDA note that none of the likely replacements appears to have the sustained level of commitment to FDA resources and regulatory issues that the Massachusetts Democrat did.

Kennedy, who first ascended to the chairmanship of what was then the Senate Committee on Labor and Human Resources in 1981, died Aug. 25 after more than a year of battling brain cancer.

Sen. Chris Dodd, D-Conn., temporarily has filled in as HELP chairman, although he would have to leave his chairmanship of the Banking Committee in order to lead HELP permanently.

In terms of Democratic seniority on the committee, Sens. Tom Harkin, D-Iowa, and Barbara Mikulski, D-Md., follow Dodd.

The senators behind Kennedy all are capable and likely would give significant attention to FDA, said David Nexon, who served 22 years as HELP's staff director for health and as Kennedy's senior health policy advisor.

However, "Sen. Kennedy had kind of an unmatched store of knowledge about FDA issues; he had been working on them so long," said Nexon, now senior executive VP for medical device industry association AdvaMed.

He cited Kennedy's aggressiveness and passion in driving the creation of drug and device user fee programs, moving the FDA Amendments Act of 2007 through the Senate and developing solid relationships with every agency commissioner.

Food and drug attorney Stephen Mahinka, a partner with Morgan, Lewis & Bockius in Washington, agreed that, despite the work the other senators have done relating to FDA, the next HELP chair inevitably will fall short of Kennedy when it comes to agency issues.

"The bottom line is that none of these folks have really made the FDA regulation and its scope a huge issue to them. They've been focused elsewhere," Mahinka said.

"If you contrast that with Kennedy's focus, it's really a very great difference."

Next In Line

Dodd may be swayed to drop the reins at Banking, where he has faced criticism in the wake of Wall Street's collapse, Mahinka said. Moving to chair HELP may also be a boon for his 2010 re-election bid.

During an Aug. 26 media call, Dodd said he has not given the question of chairing HELP permanently "a second's worth of thought." He added he plans to discuss it with Democratic leadership and make "a decision down the road over the next few days."

The Connecticut Democrat is well aware of the interests of the biopharmaceutical industry - the largest drug company in the world, Pfizer, has its global R&D headquarters in his state - but generally has taken a broad perspective on health care issues.

Dodd currently chairs the HELP Subcommittee on Children and Families. In 1997, he authored the bill establishing the pediatric exclusivity program - the Best Pharmaceuticals for Children Act. He was also a lead sponsor on related 2003 legislation - the Pediatric Research Equity Act - that provides FDA with the authority to require pediatric studies for certain drugs.

The pediatric exclusivity program may be Dodd's best known drug initiative. It provides a period of marketing exclusivity to manufacturers who perform safety and effectiveness studies on drugs in children. The law also requires FDA to prioritize review of pediatric drug applications.

Dodd has remained closely involved in renewing the program and has kept a watchful eye on balancing its benefits for children with the marketing advantages provided to the drug industry.

Many believe Harkin is unlikely to surrender the Agriculture Committee chairmanship to take over HELP, where he has played a lead role in drafting health care reform legislation. Harkin is a dietary supplement booster who says he will oppose any legislation to make regulation more burdensome to industry (¹ (Also see "Sen. Harkin Defends DSHEA, Promotes Supplements In Health Legislation" - Pink Sheet, 20 Jul, 2009.)).

Mikulski as HELP chairwoman would "probably be the best from an administrative, funding, operational standpoint" for FDA, Mahinka said. He noted the agency's facilities and employees are located in Mikulski's state.

Like Dodd, Mikulski has supported the concept of a more independent drug safety office within FDA. She has also been vocal in criticizing what she describes as the politicization of scientific decisions at FDA, in the context of the agency's earlier delay in granting OTC status to the Plan B emergency contraceptive (² (Also see "Daschle’s Prescription For FDA: Leadership, Policy, Funding And Coordination" - Pink Sheet, 19 Jan, 2009.)).

Both Harkin's and Mikulski's offices declined to discuss the senators' plans or expectations for HELP.

While no potential successor boasts a track record in health and FDA areas comparable to Kennedy's, the level of oversight and funding for the agency likely will not change substantially, said Daniel Fabricant of the Natural Products Association.

"If you go through that list, you really see a bunch of folks who, over the years have gone, 'Look, we want more money for FDA to go out and do enforcement,' whether it's Dodd, Harkin or Mikulski," said Fabricant, the trade group's interim executive director.

Loss Of A Leader

Kennedy facilitated dialogue between opposing sides of issues and sought to "bring everyone to the table and make sure everyone's voice is heard," Fabricant said.

Over the years, Kennedy loomed large over legislation affecting drugs, foods and dietary supplements.

Loren Israelsen, executive director of the United Natural Products Alliance, recalled Kennedy's influence in passing the Dietary Supplement Health and Education Act.

"I well remember that during the most tempestuous days of negotiation during DSHEA, Sen. Kennedy's staff, while tough, were always principled and good to their word. That is a reflection of how their boss wanted it," Israelsen said in an e-mail.

In 1994 leading up to the passage of DSHEA, Kennedy spoke on the Senate floor about the need for a "protective safety standard to assure the ability of the FDA to act quickly to remove products that are dangerous," and also voiced concern about the accuracy of supplement health claims.

More than a decade later, Kennedy staffers helped write the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, which required reporting of serious adverse events linked to the products (³ (Also see "History Says Industry Needs Post-AER Bill Response Plan – Ullman" - Pink Sheet, 15 May, 2006.)).

Kennedy continued to champion health legislation after taking ill in 2008. He introduced the Senate version of the Family Smoking Prevention and Tobacco Control Act, establishing the Center for Tobacco Products within FDA. Dodd ultimately shepherded the bill through to passage during Kennedy's absence from Washington (⁴ (Also see "Tight 90-Day Countdown To Create Tobacco Center Poses Challenge To FDA" - Pink Sheet, 15 Jun, 2009.)).

Also in 2008, Kennedy offered proposals for a Senate version of the FDA Globalization Act. The HELP chairman favored instituting a risk-based approach for FDA foreign facility inspections, in contrast to the discussion draft offered by Rep. John Dingell, D-Mich., who was critical of that strategy.

Sen. Dick Durbin, D-Ill., went on to carve out the food portion of the bill for the FDA Food Safety Modernization Act, S. 510, which Kennedy co-sponsored and which awaits consideration by the Senate (⁵ (Also see "Durbin Food Safety Bill Emphasizes Targeted Fees, Industry Responsibility" - Pink Sheet, 9 Mar, 2009.)).

"Had he been back at full health, I think we probably would've had a food safety bill [enacted] by now, even though his major focus would have been on health reform," Nexon said of Kennedy.

Nexon is representative of the influence and peripatetic presence of former Kennedy staffers in government, private law and health policy.

Kennedy's office additionally remained a major power broker in his final months, as the Obama administration filled out its slate of federal appointees.

The selections of Margaret Hamburg and Josh Sharfstein as FDA commissioner and principal deputy likely resulted from a compromise between Kennedy, whose choice was Hamburg, and Rep. Henry Waxman, D-Calif., for whom Sharfstein is a former staffer (⁶ (Also see "Hamburg/Sharfstein Choice Underscores Public Health, Food Safety" - Pink Sheet, 16 Mar, 2009.)).

- Dan Schiff ( ⁷ [email protected] )