Capitol Activities Signal Changes at the FDA

Date: Feb 01, 2007

The U.S. Food and Drug Administration (FDA) often finds itself a popular target for the residents of Capitol Hill. Changes on the Hill as a result of the last election could shake-up the way that FDA does business.

Although Andrew von Eschenbach was nominated to be the FDA commissioner back in March 2006, his confirmation had been held up. A series of objections by senators raised issues involving drug safety, the agency's delay of Plan B, its reluctance to allow drug reimportation and the sale of prescription drugs at lower prices in Canada.

Well, now that his confirmation is official, von Eschenbach can probably expect to spend a lot of his time on the Hill. With the Democrats now in control of both the U.S. House of Representatives and the Senate, we expect some significant changes to the make-up of the congressional committees having oversight over the FDA.

Representative John Dingell (D-MI) will chair the House Energy and Commerce Committee. Dingell's priorities include dietary supplements, generic drugs and drug safety. With regard to dietary supplements, the Committee is likely to consider whether the FDA should be given greater authority to regulate the manufacture of dietary supplements to better ensure safety. With respect to generics, Dingell may seek to shorten the current delay generic drugs experience in reaching the market.

Representative Henry Waxman (D-CA) will chair the House Government Reform Committee. Waxman is likely to tackle drug, device, food safety, enforcement and drug reimportation issues.

Regarding food safety, Waxman may use recent food contamination incidents as ammunition for increased inspection resources.

The Government Accountability Office (GAO) is adding weight to Waxman's position. The GAO has added food safety to its list of "high risk" programs that in its opinion needs "fundamental re-examination." The GAO report, seemingly calling for a single federal agency, states that, "The current fragmented federal system has caused inconsistent oversight, ineffective coordination, and inefficient use of resources."

Thus, we can expect the idea of a single food agency to arise again. Maybe this time it will be given more serious attention than in the past.

More money maybe?

Additionally, we can expect increased funding for the FDA, especially in the food area. The Bush Administration is already expected to suggest a $11 million bump for food safety, and with the Democrats in charge of congress, that ante is likely to be raised.

Whether that will help or hinder the continuation of the Food Contact Notification (FCN) program is tough to say, though. If some of the administration's proposed new funding comes from re-aligned priorities, then the FCN program could well be on the chopping block.

However, a sympathetic and understanding congress may decide that the relatively small amount needed for the continuation of the program can be provided without cutting spending on other important food safety initiatives.

Used with permission. Copyright FOOD & DRUG PACKAGING, February, 2007.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com.