Drug companies have clamored for the FDA to provide a more efficient pathway to gain product approvals, and this year the agency and U.S. lawmakers appear to be supportive of a plan that would help pharma groups race to the market with breakthrough drugs.
As Reuters reports today, the plan is expected to become law this year, formalizing a regulatory pathway that allows the FDA to let drugmakers conduct speedier trials with fewer patients prior to approval when their treatments provide major benefits for patients. The system would be akin to the agency's accelerated approach to ushering life-sustaining HIV treatments onto the market.
U.S. regulators have shown a willingness to take urgent action on reviews of breakthrough drugs. For instance, the agency stamped an approval of Vertex's ($VRTX) cystic fibrosis therapy Kalydeco after a quick three-month priority review rather than the standard 10-month review period. And the agency has acted quickly on applications for string of cancer meds such as Pfizer's ($PFE) lung cancer drug Xalkori and Roche's ($RHHBY) Zelboraf for skin cancer that showed impressive results in the clinic, Reuters reported.
Such approvals helped the industry see an uptick in market nods for new drugs, yet there are still significant barriers in place that keep development cycles even for powerful new meds long and expensive. Dr. Janet Woodcock, the FDA's top drug regulator, has been a vocal advocate for giving the agency greater latitude to approve breakthroughs.
"What happens when you have a breakthrough drug that shows an effect that's never been seen before?" Woodcock said in March, as quoted by Reuters.
- check out Reuters' article