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The accelerated approval debate: faster FDA drug approvals may mean less efficacy data.

Twenty years ago, Congress set up the accelerated approval pathway for HIV and cancer medications to help speed new treatments that provided some measure of hope to patients in need. In some cases, such as HIV, the initiative led the way for a whole new standard of therapies that saved lives. 
 
Now, the drug industry, spearheaded by lobbyist groups like the Biotechnology Industry Organization (BIO), has begun a legislative offensive backing a string of proposed laws that would significantly expand that accelerated approval pathway. Bills penned by bipartisan legislators in both the Senate and House would pressure the U.S. Food and Drug Administration to extend approvals based on compelling proof-of-concept data, allowing lengthy and expensive late-stage studies to occur after the therapeutics hit the market. 
 
If they’re successful in easing the bills through Congress, payers could be forced to reckon with a new breed of pricey therapeutics that would debut with less efficacy data — presenting payers with thorny coverage questions. And those questions would be arriving at a time when many in the biotech industry feel that payer risk — the possibility that payers will restrict access to or refuse to cover newly approved drugs — is growing into one of the most important challenges in the development process. 
 
 
 
 
 
Payers “feel the FDA should be doing a better job of weeding out drugs that do an inadequate job,” says Acorda Therapeutics CEO Ron Cohen.