A Bigger, Bolder Agency - Pharmaceutical Executive

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A Bigger, Bolder Agency


Pharmaceutical Executive


The Obama administration's determination to reform the nation's healthcare system will involve FDA in a number of issues. The potential for savings from the speedier approval of generic drugs and from authorization of follow-on biologics will put those topics on the front burner, and proposals to curb DTC advertising are likely to resurface, particularly if analysts can demonstrate that marketing curbs would reduce spending and enhance the safe use of medicines.

Hamburg and Sharfstein should get some help in dealing with Congress from new senior counsel David Dorsey. Formerly a top staffer to HELP Committee chairman Edward Kennedy (D-MA), Dorsey played a lead role negotiating bills to authorize user fees, pediatric studies, and the FDA Amendments Act (FDAAA) of 2007, as well as working closely with Kennedy on his proposal for authorizing biosimilars.

Building on FDAAA

Current legislative proposals would enhance FDA enforcement powers beyond the increased fines and criminal penalties authorized by FDAAA. So far, FDA has not brought a case under this new authority, but "when we need to use it, we will," said Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER).

"Enforcement will increase," she promised at the April annual meeting of the Food and Drug Law Institute (FDLI).

Autor pointed to a rise in injunctions, investigator disqualifications, and warning letters, and advised companies to avoid getting the agency's "big stick" by being proactive about compliance. In five years, her staff has grown from 150 to 250, increasing its capacity to take regulatory action. As of April 14, 2009, CDER had issued almost 40 warning letters—that's nearly half the 87 sent out in all of 2008. Autor cites the agency's speedy action in halting production and requiring recalls due to repeat manufacturing violations by KV Pharmaceuticals. Similarly, the agency moved quickly to close down Coast IRB following revelations that this independent review board had approved a fictitious study presented in a sting operation by the Government Accountability Office. Data integrity also is important, Autor said, advising due diligence by companies involved in corporate mergers and acquisitions to verify the quality of submissions to the agency.

In addition, FDA's campaign to remove unapproved drugs from the market remains a high priority. Even though this effort has affected over 200 manufacturers and involved actions against 12 classes of drugs, "we still see industry as somewhat complacent," Autor said. She stressed that manufacturers must understand that FDA approval is imperative for all drugs.

Globalization of drug manufacturing and product testing is another issue that further stresses FDA oversight capacity. Foreign drug manufacturing sites now exceed registered domestic facilities, and the volume of drug products made overseas continues to rise. FDA is boosting staff in its overseas offices, and plans more aggressive monitoring of foreign operations and tactics (such as Chinese "show" and "shadow" factories—a clean facility presented to FDA inspectors that masks production at a shoddy plant). However, the agency emphasizes that manufacturers are wholly responsible for the ingredients and the quality of their finished products. "Look for red flags," Autor advised. Lax regulation in a market or a significant decline in an important ingredient may be open invitations to dishonest behavior.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at


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