Drugmakers, groups lobby for user-fee changes

The FDA is already preparing to renegotiate the pharma user fees that expire in September 2012--and there are plenty of folks already trying to influence the process.

To be fair, the agency has asked for input into the renegotiation endeavor, and they got just that at a public meeting yesterday. Consumer and patient groups are lobbying the FDA to use the fee negotiations to push for other changes. For instance, Reuters reports, many groups are pressing the agency to collect enough money from drugmakers to hire more staff to review DTC advertising before it reaches consumers. "By the time FDA determines an ad is misleading, it has already been seen by thousands if not millions," Diana Zuckerman, president of the National Research Center for Women & Families, said at the meeting. "That has to change."

Meanwhile, Consumers Union wants the agency to require new medicines to be tested against existing remedies for the same condition, rather than against placebo. That idea has been tossed around quite a bit already, especially as treatments for some maladies multiply. Consumers Union's William Vaughan also pressed for clearer drug labels that include a "fact box" summarizing risks and benefits (another idea that plenty of others are backing, too).

For their part, drugmakers are supporting an extension of the user fees that now support review of drug applications. But they want the review process to be more efficient--i.e., faster. As the user-fee-supported process has evolved to include risk-management programs and the like, it's slowed down as well, a PhRMA representative said at the meeting. FDA needs to "address this breakdown in order to deliver safe and effective new medicines to patients without unnecessary delays," PhRMA's Dr. David Wheadon said.

What next? FDA and drugmakers will actually start negotiating in June, Reuters says, aiming to finish their talks by January. The proposals will come up for public review in late 2011.

- read the Reuters piece