Speedy drug-review process 'broken' US Congress wants to take action

Since 1992, companies pledged to complete 91 clinical trials in exchange for the FDA's speediest drug review. Some 42 of the promised studies remain unfinished, including those for such blockbuster drugs as the cancer treatment Gleevec, Markey,Democrat of Malden alleged. Twenty-one of the studies have not been started, while 18 are on or ahead of schedule, according to Markey's research. His office relied on FDA data and did not contact drug companies directly. Under legislation he expects to introduce next week, drug companies could face millions of dollars in fines if patients are harmed because tardy trials keep some health risks from being publicized. The proposed legislation would require drug companies to change the wording on labels to indicate that the safety and efficacy of conditionally approved products have not been proven.

Speedy drug-review process 'broken' - The Boston Globe - Boston.com - Business

BioBOOM Op/Ed: And you wonder why we think the R&D budgets will be tighter with more budgets shifting to legal, PR and regulatory? Seems like some of these companies need a good management shake up. And we don't mean bring on more outside the sector MBA's or finance types, who despite platitudes seem more interested in the bottom line than saving lives. (hint hint: chase the cures,not the revenue and the money will come) We fear the environment they have managed themselves into has shifted the past 5 years from good medicine to greed medicine in the public eye and the reaction we see from the general public, media, and now their reps in congress shouldn't be unexpected. Any strong ethical leadership around in the sector anymore? Fewer and fewer we fear. Because this kind of government intrusion that their mismanagement has caused will also be a problem for investors including the little old lady from Iowa who's 401k was used in hoping to help others

1 comment:

Anonymous said...

Your right on - Merck is introducing the first campaign in its 114-year history to help burnish the reputation of its corporate brand rather than sell its products. Less money for R&D

Blog Archive