Drug Industry Contributes to Supporters of FDA Bill

Senators who "raised millions of dollars in campaign donations from pharmaceutical interests secured industry-friendly changes" to a bill (S 1082) approved on Wednesday by the Senate, USA Today reports. The measure would extend until 2012 the Prescription Drug User Fee Act, which is set to expire on Sept. 30.

The legislation, which passed on a 93-1 vote, includes a number of provisions to expand the authority of FDA to monitor prescription drug safety. However, the "powers granted to the FDA in the bill's original version were pared back during private meetings," and "efforts to curb conflicts of interest among FDA advisers and allow consumers to buy cheaper drugs from other countries were defeated in close votes," USA Today reports.

According to USA Today:

• The 49 senators who voted for a second-degree amendment to the legislation that effectively nullified an amendment to allow prescription drug reimportation have received about $5 million from pharmaceutical industry executives and political action committees since 2001, almost three quarters of the donations from the industry to current senators, according to an analysis of data compiled by the Center for Responsive Politics and PoliticalMoneyLine.
• Sen. Pat Roberts (R-Kan.), who has received $18,000 in donations from the pharmaceutical industry this year and $66,000 in donations since 2001, proposed an amendment to the bill to replace a provision that would have allowed FDA to require pharmaceutical companies to wait two years before they air television advertisements for new medications with a provision that would allow the agency to fine companies for false or misleading ads. Roberts said that the replaced provision would have violated the First Amendment rights of pharmaceutical companies. Roberts spokesperson Sarah Little said that the senator "takes great pains to keep fundraising and official actions separate."
• Sen. Judd Gregg (R-N.H.), who has received $168,500 in donations from the pharmaceutical industry since 2001, proposed a revision to the bill that limited the authority of FDA to require pharmaceutical companies to conduct post-market studies of new medications.
• Sens. Edward Kennedy (D-Mass.), who has received $78,000 in donations from the pharmaceutical industry since 2001, and Mike Enzi (R-Wyo.), who has received $174,000 in donations, after they met with industry executives and others, agreed to revise the legislation to limit a requirement that pharmaceutical companies make public all clinical trial results. The senators said that the donations from the pharmaceutical industry had no effect on the decision to revise the bill.

Sen. Bernie Sanders (I-Vt.), the only senator to vote against the bill, said, "It's not that money buys votes. But you have a culture in which big money has significant influence. Big money gains you access, access gives you the time to influence people."

Ron Pollack, director of Families USA, said, "I don't think there is any lobbying group in town that has the clout of the drug industry."

However, Ken Johnson, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said that critics "never point out that a great deal of this money is spent trying to defeat bills ... that are designed to cripple this industry" (Dilanian, USA Today, 5/11).

In related news, the New York Times on Friday examined how Kennedy and Enzi, in an "unusual display of bipartisanship," partnered to "fend off amendments that would have made the bill unacceptable to the White House, raised the ire of the pharmaceutical industry or jeopardized chances for passage."

According to the Times, "Mr. Enzi is as conservative as Mr. Kennedy is liberal," but "both are pragmatic legislative craftsmen."

Enzi said, "Kennedy and I have developed a trust. We don't try to run over each other. We have a history of passing bills -- 27 signed by the president in the last two years."

Gregg, who voted against the bill in the Senate Health, Education, Labor and Pensions Committee but later worked with Kennedy and Enzi for passage of the legislation in the full Senate, said, "There's a Ted Kennedy who is quite flamboyant and partisan in the theater of the Senate," and "there is a Ted Kennedy who is extremely bipartisan and willing to work with people in the back rooms of the Senate" (Pear/Harris, New York Times, 5/11).

The Senate passed the reauthorization bill "by such an overwhelming margin ... that some much-needed changes now seem likely to gain full Congressional approval and become law," but the "downside is that an amendment to allow the import of safe and inexpensive prescription drugs from abroad had to be eviscerated to get a veto-proof majority," a New York Times editorial states.

The legislation includes "welcome" provisions that would provide FDA with more authority to require pharmaceutical companies to conduct post-market studies of new medications and "order changes in warning labels without haggling for months with the manufacturers," according to the editorial. "Unfortunately, the bill would also push the agency into even greater reliance on user fees from the pharmaceutical companies to finance its drug review activities," a "dangerous dependency that distorts how the agency allocates money and staff and how fast it reviews drugs," the editorial states.

In addition, although the Senate approved a second-degree amendment to the legislation that effectively nullified an amendment to allow prescription drug reimportation in part to avoid a veto threatened by President Bush, supporters of the provision "should find a new way to bring it to a vote," the editorial concludes (New York Times, 5/11).