The 'Right to Try' law says yes, the drug company says no

Although the "Right to Try" bill was signed into law in late May to help patients with life-threatening conditions get faster access to investigational drugs by bypassing FDA's normal approval process, drug companies still have the final say on such requests.

Although the "Right to Try" bill was signed into law in late May to help patients with life-threatening conditions get faster access to investigational drugs by bypassing FDA's normal approval process, drug companies still have the final say on such requests. Arthur Caplan, head of medical ethics at NYU School of Medicine, established and oversees a program for making decisions about compassionate use for Johnson & Johnson. He says drug companies generally prefer the structure of FDA approval, even if they have more freedom to circumvent it now. "They think it protects them from manufacturing useless drugs or making things that might have dangerous side effects that would create a legal nightmare for them," he notes. Ron Cohen, president and CEO of Acorda Therapeutics and past chairman of BIO, a trade group representing the biotechnology industry, says only about 10% of drugs tested in humans make it to the marketplace. Supplying a drug for compassionate use requires companies to divert product meant for clinical trials, he says. Some companies do not have the resources to do that.