Patients could soon see an influx of cheaper generic medication onto the market following the US Food and Drug Administration's (FDA) unveiling of new steps to stimulate drug competition and improve access to generic drugs.
It published a list of branded off-patent medication currently without approved generic alternatives in a drive to encourage pharmaceutical firms to submit applications for new generic drugs. Furthermore, it announced a policy to hasten the review and approval process for new generic drug applications. The two measures are the first phase of the Drug Competition Action Plan announced by FDA Commissioner Scott Gottlieb, MD, last month.
The FDA hopes the latest measures will boost availability of generic drugs such as atorvastatin or ramipril in the US marketplace, improving patient access to cheaper prescription medication. "Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren't used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options," Gottlieb stated. He reasserted the regulatory body's commitment to reducing the financial burden faced by many patients as a result of their medication expenses, adding that further steps will be taken to tackle this in the near future.
The "swift and decisive action" by the FDA Commissioner was welcomed by the Association for Accessible Medicines (AAM), which suggested increasing drug competition and availability of generic and biosimilar medicine should be an integral part of government efforts to reduce drug costs for patients. Commenting on the announcement, Chester "Chip" Davis Jr., president and CEO of AAM, said improved access to "safe, effective and affordable" generic medication would be of "tremendous benefit for our nation's patients".
Last year, generic drugs accounted for nine out of ten (89%) prescriptions filled in the United States, yet only 27% of the drug costs, according to the Generic Drug Savings and Access in the United States report compiled by QuintilesIMS Institute on behalf of the Generic Pharmaceutical Association. Generic medication provides patients with a low-cost alternative to more expensive branded drugs. When a new product is developed, the pharmaceutical firm has a limited period, typically 20 years, in which they have have exclusive rights to their branded medication, after which other companies may submit Generic Drug Applications to the FDA for approval. The FDA's latest policy will prioritize Generic Drug Applications for branded medications with less than three generic options available.
In 2017 to date, the FDA has announced 34 First-Time Generic Drug Approvals permitting manufacturers to market a generic drug in the United States. The most recent was for emtricitabine and tenofovir disoproxil fumarate tablets, a generic HIV-1 treatment based on the branded medication Truvada. Other medication granted approval include Zydus Pharmaceuticals' mesalamine delayed-release tablets USP (a generic of Lialda), and a generic of Vytorin (ezemitibe and simvastatin) produced by Impax Laboratories.
