In an already politically charged year for the FDA, U.S. Senator Kay Hagan is spearheading legislation that would expedite reviews and approvals of drugs against serious medical conditions, her home state's North Carolina News Network reported.
The report says the legislation aims to give speedier reviews to drugs that deliver major benefits to patients, including targeted meds for patients with serious diseases and therapies that address underserved medical needs. The details of the North Carolina Democrat's plan were scant, and it's unclear exactly how quick she wants reviews to be. The FDA, of course, already has practices in place to speed new drugs to market if they offer superior benefits to patients, among other things.
“But for patients suffering today from some diseases for which there are no current treatments or for those patients who are clutching to the hope that a better treatment will be developed for their rare diseases, medical advances cannot come fast enough," said Hagan, as quoted by NCNN. She pointed to successful programs that sped new HIV treatments to patients in the 1990s to bolster her case.
Some lawmakers and biopharma backers have blasted the FDA for slowing the advance of innovative therapies to the market. FDA boss Margaret Hamburg has answered critics by emphasizing the agency hit a 7-year high in approvals last year, so the regulator can indeed act quickly to green light drugs when warranted. Take its recent speedy approval of Vertex's ($VRTX) cystic fibrosis drug Kalydeco, which the agency blessed last month ahead of schedule. Still, agency brass will need to gain support from U.S. lawmakers to reauthorize PDUFA this year, making 2012 a good time for members of Congress to voice their hopes and concerns about how the FDA conducts business.
- check out Hagan's release
- here’s the report from NCNN
Special Report: FDA approvals of 2011