Last month's White House proposal to speed consumer access to cheaper generic drugs by curtailing brand-name patents and lawsuits drew mostly tepid reactions from pharmacy groups, some of whom remained silent on the politically volatile issue.
The proposal also drew fire from Capitol Hill, where some lawmakers saw it as a blow to efforts to pass a law limiting brand-name drugmakers' abuse of patent law and as a preelection bid to placate voters' anger over the rapidly rising cost of Rx medications.
Meanwhile, White House officials argued that their new Food & Drug Administration proposal would protect vital patents for drugmakers while improving access to generics and saving consumers an estimated $3.5 billion per year in drug costs. The FDA posted the proposed rules on its Web site on Oct. 11, opening a 60-day public comment period before the rules can become final.
Most industry groups said they were busy reviewing the plans before commenting specifically. But a lukewarm response came from chain pharmacies, which are responsible for 50% of all generic Rx fills in the United States-nearly twice the business funneled through mail-order outlets. The National Association of Chain Drug Stores posted a notice on its Web site questioning whether the rules promoted White House "policy or politics" and warning that it remains to be seen whether brand-name manufacturers will sue to keep the rules off the permanent books. Crystal Wright, the group's spokeswoman, said that the rules were "a move in the right direction. But the proof will always be in the pudding" to see if the plan really promotes more consumer choice, she said. The group prefers tighter restrictions that give even more advantage to generics, like those passed in a Senate bill earlier this year.
Generic drugmakers offered a similar reaction, restating their strenuous support of the Senate bill. While the changes are an "important step" under current patent law, they don't go far enough to ensure lower costs for consumers, said Kathleen D. Jaeger, president of the Generic Pharmaceutical Association. "We believe we could achieve a lot more savings through legislative efforts."
The Pharmaceutical Research & Manufacturers of America declined to comment specifically on the proposal. "We are seeking feedback from our board of directors," said spokesman Jeff Trewhitt. The group has strongly opposed any changes to patent rules.
The proposed FDA regulations limit brand-name firms' ability to use controversial "30-month stays" to keep generic copies off the market during patent disputes. The proposal allows brand-name manufacturers only a single stay per generic challenger, regardless how many patents support the original. …