When news breaks that a new drug has received FDA approval, the company usually makes a public announcement and begins negotiating with health insurers, working on manufacturing and distribution channels and educating physicians and other interest groups. It may take weeks or months before the drug can begin being shipped to patients who request it through their doctors.
That timeline can be complicated by the fact that drug makers sometimes have a commitment from the FDA to review their applications within a certain timeframe, which are often referred to as action dates or PDUFA dates. Enacted in 1992 and periodically reauthorized by Congress, the Prescription Drug User Fee Act stipulates that companies pay user fees to help fund FDA review staff and, in return, the agency agrees to make a decision on new medicines within a certain period of time, often six months after receiving an application.
The agency also has long had an accelerated approval program whereby it can issue decisions within two months for drugs that treat rare or life-threatening conditions. A recent proposal from FDA Commissioner Marty Makary, however, would shorten that process even further, allowing it to take just one or two months.
This kind of reform, which critics fear would allow the FDA to skirt a core requirement for new drugs to be tested on large numbers of people over extended periods of time, could create more uncertainty about the safety and effectiveness of new medications. It’s a concern that some doctors and patient advocates have raised over the past year, including in a Medscape Medical News article by Dr. Anup Gyawali, who writes that the notion of an unmet need should not imply that the void should be filled with medicines that don’t improve or extend patients’ lives.