A Senate compromise bill passed by the U.S. House of Representatives yesterday would not only give the FDA more flexibility to inspect drug manufacturing sites overseas, but would for the first time also allow the FDA to collect fees from generic drug makers for faster approval of their therapies. According to the Associated Press, the FDA presently has a backlog of about 2,700 generic drugs waiting for approval.
Moreover, the Food and Drug Administration Safety and Innovation Act (S. 3187) contains provisions that would increase fines for drug counterfeiting and require earlier notification of potential drug shortages, something that could appease many stakeholders in the ongoing shortage crisis. A recent report issued by the House Committee on Oversight and Government Reform blames the FDA for the ongoing shortage, as well as growing market concentration of drug manufacturers and reduced reimbursement for certain injectables brought on by the Medicare Modernization Act of 2003.
Regardless of who or what is to blame, health plans and PBMs are taking steps to manage the shortage in the meantime. Express Scripts Holding Co., for instance, has said it works closely with generic drug makers to communicate its demand rate so that manufacturers can build it into their production cycles. But for a smaller firm with less pull, options may include communicating the shortage to pharmacists, members and providers so that they can come up with contingency plans and making copay exceptions to accommodate patients’ increased out-of-pocket expenses should they have to switch to a brand drug because their generic is unavailable.
The Senate is expected to vote on the bill next week. If it’s signed into law, would that change the way your organization presently handles drug shortages?