Senate passes FDA bill

After more than a week of delicate negotiations and floor maneuvering, the Senate overwhelmingly approved a bill Wednesday designed to enhance the authority of the Food and Drug Administration.

The measure passed, 93-1. The nearly unanimous vote was not surprising, given a broad consensus that the FDA vehicle was a must-pass bill. Sen. Bernie Sanders (I-Vt.) was the dissenting vote.

{mosads}Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Edward Kennedy (D-Mass.) and ranking member Mike Enzi (R-Wyo.), however, had to manage the debate amid many efforts from their colleagues to make substantial changes on the floor.

“This landmark legislation creates a stronger Food and Drug Administration and sets forth a new and better direction for the safety of the drugs we take and the food we eat,” Kennedy said.

“Today we have risen above partisan politics to deliver a monumental victory for all Americans,” Enzi said.

The underlying bill would reauthorize a program through which drug companies pay user fees to the FDA to get their products reviewed for approval, and the FDA agrees to meet certain performance goals about those reviews. The measure also would reauthorize a similar program for the medical-device industry. These provisions were based on agreements struck between the FDA and industry.

The main potential roadblock to passage — and the source of a veto threat from the White House — was language to allow the importation of medicines, which would reduce their prices in the United States. Although Sen. Bryon Dorgan’s (D-N.D.) amendment passed, it did so with strings attached.

The Senate adopted other language, offered by Sen. Thad Cochran (R-Miss.), requiring the Department of Health and Human Services to affirm the safety of drugs from abroad, something the department has refused to do in the past.

Kennedy and Enzi, working with Sens. Hillary Rodham Clinton (D-N.Y.), Orrin Hatch (R-Utah) and Charles Schumer (D-N.Y.) also punted on the controversial issue of granting the FDA the power to approve generic versions of biologic drugs. The HELP Committee instead will mark up the legislation on its own, under the agreement between the five senators.

Kennedy and Enzi added key elements to their bill that were not included in the FDA-industry agreements. The bill would grant the FDA new authorities to require companies to track the side effects of their drugs after they reach the market and for the FDA to take actions if signs emerge that the medicines are harmful.

These so-called post-marketing safety requirements were drafted largely in response to the experience of drugs like Merck’s Vioxx, which was pulled from the market in 2004 when evidence mounted linking the drug to strokes and heart attacks.

The final version of the bill also included language offered by a number of senators from both parties. Majority Whip Dick Durbin (D-Ill.) sponsored legislation on human and pet food safety in response to recent cases of contaminated foods. Sens. Sherrod Brown (D-Ohio), Richard Burr (R-N.C.), Cochran and Hatch offered language to promote the development of new antibiotics. Brown and Sen. Debbie Stabenow (D-Mich.) sponsored an amendment that would limit drug companies’ use of “citizens petitions” to the FDA as a means of postponing the introduction of generic versions of drugs.