Diagnostics & Imaging Week Washington Writer

WASHINGTON – With the Democrats taking the White House and making big gains in both the House and Senate last week, congressional oversight of medical product safety will shift from the FDA to industry, and device and drug makers should be prepared to be in the crosshairs, said John Manthei, global co-chair of the healthcare and life sciences practice at the Washington law firm Latham & Watkins.

"Congressional oversight is an intensely political process," Manthei said Wednesday in a post-election call with reporters.

The current Democratic chairmen of the healthcare-focused congressional committees have done a "remarkable job" in highlighting the failures of FDA under the Bush administration, he said. "I don't think the Democratic congressional investigators are going to be anxious to pull up the Obama political appointees and subject them to the same level of criticism," he said.

Instead, Manthei said, the 111th Congress will be focused on making sure manufacturers are forthcoming with regulators about emerging safety data related to their products and that the industry is "playing its role within the fundamental integrity of the FDA regulatory process."

Gone are the days of the "five-year comfort zone" of major FDA reform, which over the past two decades has been tied to the passage of bills reauthorizing drug and device user fee programs, said Manthei, majority counsel to the House Energy and Commerce Committee from 1998 to 2000.

He predicted that bills affecting FDA and medical product makers will now come to the floor more rapidly, being passed yearly rather than waiting to be attached to a larger piece of reform legislation, such as the Prescription Drug User Fee Act, which has come up for renewal every five years since 1992.

Therefore, Manthei said, the medical product industry is going to need to be more engaged with the legislative process and "watch it closer than they have in the past."

Legislation creating a regulatory pathway for the FDA to approve follow-on biologics, also called biosimilars, is going to be "front and center" on Congress' agenda early next year, Manthei surmised.

He said he also expects lawmakers to take action fairly quickly on re-importation bills – legislation that would allow drugs produced by U.S. manufacturers that are shipped and sold in Canada and Europe to be re-imported by U.S. patients into this country – given that President-elect Barack Obama (D-Illinois) has shown support for the legislation in the senate.

Depending on the outcome of the preemption case that came before the Supreme Court Monday, which could decide whether FDA approval of a drug preempts the right of a consumer to sue a manufacturer in state court if a medication later causes injury, legislation involving that issue also could come to the floor next year.

Additional funding for the FDA also will be a top priority for the Democrats in 2009, he said.

Manthei said he also expects Congress to extend FDA's regulatory jurisdiction to include tobacco products. "That would be a significant undertaking for the FDA," he said, adding that such a move could shift the agency's focus away from its other priorities.

However, he said he anticipates that Congress will fund the FDA's tobacco regulatory activities "almost exclusively" through user fees imposed on that industry. Nonetheless, he said adding tobacco to the FDA's regulatory responsibilities could consume the attention of whoever takes the commissioner's job, since the agency will basically be starting from scratch with rule-making for the tobacco industry.

Manthei said it is "too early" to know who will be placed in the FDA commissioner's job, and said he is unaware of anyone specifically on Obama's list for consideration. He noted that Susan Alpert, senior vice president and chief regulatory officer for Medtronic (Minneapolis) and a former high-ranking official in the agency's Center for Devices and Radiological Health, has been mentioned in certain circles as a potential contender.

However, Manthei emphasized that as far as he knows, Alpert is not on any definite list and no one has emerged as an early candidate for the FDA chief's job.

He noted that Sen. Edward Kennedy (D-Massachusetts), chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, has indicated that he did not want anyone from the drug or device industries to fill that slot.

"It will be interesting if that selection criteria will still hold," Manthei told reporters. "That obviously is going to eliminate a number of potentially very qualified applicants."

The FDA's chief counsel also is a political appointment that Congress must ensure gets filled quickly, Manthei said, adding that it also is too early to know who Obama will nominate for that job.

The outcome of the election will bring little change to key congressional healthcare committees in the 111th Congress, since the Democrats already hold the chairmanships, Manthei maintained.

However, he noted that with the retirement of Rep. Tom Davis (R-Virginia), whose 11th District Virginia seat was won Tuesday by Democrat Gerald Connolly over Republican Keith Fimian, the GOP will need to install a new ranking member on the House Oversight and Government Reform Committee.

That committee's chairman, Rep. Henry Waxman (D-California), has initiated several of the current ongoing investigations into the FDA and has authored several FDA bills, Manthei added.

Presumably, Kennedy will continue to lead the Senate HELP Committee, he said. However, if Kennedy, who is battling brain cancer, is unable to resume his duties, Sen. Christopher Dodd (D-Connecticut) would likely fill that chairmanship position, Manthei said.

The real wild card in the Senate for a "brand new player" in the healthcare-focused committees rests with Sen. Hillary Clinton (D-New York), Manthei said, noting that while Clinton has been very involved in healthcare legislation and policy since coming to the Senate in 2000, her time over the past two years has widely been consumed by her presidential bid, which was extinguished by Obama earlier this year.

"Most people would fully expect her to emerge as a key player," he said. "She's obviously very well respected, smart, and brings a tremendous amount of experience and expertise on health."

The healthcare legislative agenda for the House and Senate will be "largely coordinated," Manthei said, with reform focused on controlling costs and increasing access.

Given the way Congress, specifically the House, was restructured after Tuesday's election, Republicans are going to have a "harder time" impacting the legislative process, he argued.

Since there has been a consensus among Democrats that FDA has failed to live up to its expectations and has not aggressively enforced the laws already on the books, "I think we should fully expect to see a much more aggressive FDA as we move into 2009," Manthei added.