FDA operational problems will continue to be a prime target for congressional oversight, a House Republican staffer advised the Food and Drug Law Institute annual meeting April 23.

The General Accountability Office's conclusion that FDA's medical product oversight programs are not working is "a signal to Congress of the great need to address a number of issues involving the Food and Drug Administration," explained Alan Slobodin, the Republican chief counsel for oversight and investigations at the House Energy and Commerce Committee.

GAO in January listed FDA's operations as a high priority for oversight (¹ Also see "FDA’s Dubious Honor: GAO Flags Many Of Its Activities As “High Risk”" - Pink Sheet, 2 February, 2009., p. 36).

That conclusion indicates "the staggering task that faces the Food and Drug Administration with the resources and, in some cases, the authorities that it has," Slobodin said.

The fact that the administration and Congress are now controlled by the same party suggests the relationship between the Commerce Committee and FDA would be less adversarial.

But Slobodin noted that the oversight agenda adopted by the committee indicates the agency will "continue to be a pretty major topic area." However, Democratic members of the committee must still decide on specific projects.

Investigations that began in the 110 Congress that could be continued include FDA handling of information technology projects and use of bonuses.

On the Republican side of the panel, investigators plan to continue to look into the safety problems that arose with heparin and "have a number of oversight projects involving FDA's contracting," Slobodin reported (² Also see "FDA Employee Misconduct Charges To Be Investigated By OIG Instead Of Itself" - Pink Sheet, 19 November, 2007., p. 14).

The importance the committee attaches to food, drug and device safety can be seen in its past record, he noted. Of the last 40 oversight hearings conducted by the committee, almost half dealt with those issues.

The most recent examined a GAO sting operation of institutional review boards in which Coast IRB approved a bogus device clinical trial protocol and subsequently agreed to curtail its operations (³ Also see "IRB Quality Concerns Take Center Stage After FDA Clamps Down On Coast" - Pink Sheet, 20 April, 2009., p. 17).

The investigation and subsequent warning letter from FDA basically put the firm out of business. Coast on April 24 sent a letter to its clients, advising them that it is transitioning its studies to Columbia, Md.-based Chesapeake IRB. FDA is being kept informed of the transition activities.

The GAO investigation generated "a lot of concern" and "dovetails into other oversight issues that also are related to clinical research that we could eventually be getting into," Slobodin added.

"To some it seems that FDA's kind of the Charlie Brown here, the committee's always picking on them," he noted. But the oversight activities show "how important this agency is. ... Members and the public have a great deal of interest in it."

New Legislative Cycle

Congressional focus on FDA issues continues in the legislative area as well and translates into the need for industry to continually track potential changes in how FDA does business.

Industry must get out of its "five-year comfort zone" with regard to legislation, John Manthei of Latham & Watkins told FDLI.

The five-year renewal period for the user fee program will no longer be the basis for drug and device legislation, he noted. The must-pass nature of PDUFA reauthorization was the way to force consensus on other issues and "drive other reforms out at the agency," he explained.

Now, the Democrats control both houses of Congress and the administration and they are looking at a variety of issues that will not be delayed for the next PDUFA renewal in 2012, he predicted.

Industry needs to brace itself "for FDA legislation being really an annual event at this point."

Major issues such as follow-on biologics, disclosure of payments to physicians and increased oversight of foreign facilities are holdovers from the 110 Congress that are expected to see action at some point this go-round.

But Congress also is looking at topics that are not page one stories for the general press although they are important to industry. These include preemption, restrictions on direct-to-consumer advertising, and Energy and Commerce Committee Chair Henry Waxman's criticism of FDA's off-label guidance, Manthei noted.

From an industry perspective, they are "all things that have a dramatic impact on the day-to-day operation of our companies. At the end of the day, industry needs to be prepared to engage the Hill to make sure that our perspective on these issues is actually heard," because they are not going to lie dormant until the next five-year FDA legislative cycle comes around. "It's a new day."

Looking ahead to PDUFA V, Manthei noted the importance of keeping FDA's feet to the fire on drug approval timelines. Those commitments, as well as the fees, must be part of the process, he said. "It's going to be critical for industry to be able to make sure that Congress sees that and participates in that debate."

Industry also must add its voice to the discussion on how to ensure food and medical product safety in an era of globalization, he said. Foreign regulators, as well as FDA, are struggling with this issue. Authorities across the globe will have to harmonize their efforts and it is key that industry provide input to the debate, he stressed.

- Cathy Dombrowski (c.dombrowski@elsevier.com)

FDA Stays In Hot Seat On Capitol Hill; PDUFA No Longer Drives Legislation

More from Archive

More from Pink Sheet