Congress Likely To Debate Source of Funds for FDA Oversight of Direct-to-Consumer Prescription Drug Advertisements

The FDA budget for oversight of direct-to-consumer prescription drug advertisements in fiscal year 2008 is "larger than the past five years combined," but "whether that level of funding will be sustained and continue to come from taxpayers -- or will be raised from drug makers through new user fees -- is likely to be battled out in Congress," USA Today reports.

In FY 2008, FDA received $6.1 million to determine the fairness and accuracy of DTC ads, compared with $2.2 million in FY 2007 and $1 million in FY 2006. FDA officials said that the agency plans to hire additional employees to review more DTC ads. FDA, which currently has 13 employees who review DTC ads, received materials for 12,616 ads last year.

In his FY 2009 budget request, President Bush seeks $14 million in user fees from the pharmaceutical industry to finance 27 additional FDA employees who review DTC ads. In exchange, FDA would review DTC television ads within 45 days and before the ads begin to air.

The Pharmaceutical Research and Manufacturers of America supports the use of user fees to finance FDA oversight of DTC ads. According USA Today, expedited FDA reviews of DTC ads would "help drug makers meet marketing goals and lessen the risk of running ads later cited by the FDA for false or misleading content."

However, some Democratic lawmakers -- such as House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies Chair Rosa DeLauro (D-Conn.) -- oppose the use of user fees to finance FDA oversight of DTC ads. "Congress should provide a direct appropriation in order to minimize industry influence in the FDA," DeLauro said (Schmit, USA Today, 2/25).

FDA Authority Over Imports
In related news, HHS Secretary Mike Leavitt said that the Bush administration supports a proposal that would expand FDA authority over medications and foods manufactured abroad for distribution to the U.S., the Wall Street Journal reports. In a letter to Reps. Joe Barton (R-Texas) and John Shimkus (R-Ill.), Leavitt wrote that, because companies abroad often can "deny U.S. officials access to their facilities without any adverse consequences," such a proposal "would better enable FDA to address criminal conduct that occurs entirely outside of the United States and threatens the health and safety of consumers within the United States."

Leavitt sent the letter in response to a request from Barton and Shimkus, who have lobbied for such a proposal since 2000. Barton said, "The secretary's support is good news. We have to get this right, and we have to get it right soon because the volume, variety and the complexity of products arriving from overseas is increasing every day" (Zhang, Wall Street Journal, 2/23).

Opinion Piece
The "unfolding tragedy" in which hundreds of U.S. residents experienced severe allergic reactions or died after they received injections of "Chinese-made heparin has its roots in a spectacular example of bad government that some federal watchdogs started barking at a decade ago," but lawmakers "simply did not respond adequately to the warnings," syndicated columnist Terence Jeffrey writes in the Washington Times.

A 1998 investigation conducted by the Government Accountability Office found that FDA "did not possess a complete and reliable list of the foreign manufacturers producing drugs" and that the system "put Americans at risk," Jeffrey writes. In November 2007, GAO presented to the House Energy and Commerce Subcommittee on Oversight and Investigations the results of a recent investigation that found FDA "still did not have a complete and reliable list of foreign factories making drugs," according to Jeffrey.

He concludes, "Will another decade pass before politicians fix the FDA?" (Jeffrey, Washington Times, 2/24).