Ever since 1992, when US lawmakers passed the Prescription Drug User Fee Act (PDUFA) to accelerate review of new drugs by the US Food and Drug Administration, industry money has had an increasingly important role in fueling the regulatory agency. In the program’s first year, drug companies paid less than $9 million total to the FDA through the initiative. But in the past two decades the amount has ballooned; this year, the agency anticipates receiving at least $619 million in user fees, composing roughly 65% of its budget for overseeing human drugs.
Despite the torrent of funds, the FDA has still failed to meet its goal of completing the review of 90% of new drug applications within ten months. Industry isn’t exactly pleased with this report card, and they have spent the past year in negotiations with the agency to plan how the fees can be used to make drug review more efficient.
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A US federal appeals court ruling will make it harder for patent holders to lose their intellectual property protection because of charges—often based on small errors or omissions in patent applications—that they engaged in misconduct by misleading or deceiving the patent office. Now, except in egregious cases, such legal challenges can only succeed if the missing information would have affected whether the patent was issued in the first place.
On the face of it, the takeover of six of Indian’s key drug firms by major foreign players in the past four years seems to be routine business. But people within the government and industry watchdogs in India have started to worry.
By Michelle Pflumm
By Charlotte Shubert
By Kelly Rae Chi