The US Food and Drug Administration (FDA) has announced new measures to streamline its generic drug application review process. The agency is working to reduce the number of review cycles required for generic applications before they can be approved for use in the United States, FDA Commissioner Scott Gottlieb, MD, stated.
As part of efforts to increase the number of generic drug options in US pharmacies, the FDA released two new documents to speed up Abbreviated New Drug Applications (ANDAs). The first, entitled “Good ANDA Submission Practices”, highlights common problems found in generic drug applications. These issues often lead to delays and multiple cycles of reviews, it asserted. The second, called “Good ANDA Assessment Practices”, is an accompanying manual of policies and procedures for FDA staff outlining ANDA assessment practices.
Patents for drugs usually last for 20 years, after which other pharmaceutical manufacturers may begin to market generic versions following FDA approval. Generics account for nine out of ten prescriptions filed in the United States and are required to have the same active ingredient, strength, dosage form and route of administration. A recent addition to the list of generics available came in December 2017, when a number of drug companies gained approval for generic versions of Viagra (sildenafil), previously a branded product produced by Pfizer.
However, many generic drug applications are delayed because they are submitted with insufficient information, according to the FDA. Generic drugs go through an average of four review and application cycles before they are approved by the agency. One of the key goals highlighted by the FDA for 2018 is a reduction in the number of generic medication review cycles, a target it hopes to achieve by helping applicants avoid common errors or deficiencies that lead to delays.
The latest measures are part of the FDA’s Drug Competition Action Plan announced in late May 2017. At the time, Gottlieb highlighted the benefits of improving generic drug application processes, stating: “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.”
In June 2017, as one of the first steps in its Drug Competition Action Plan, the FDA announced a new policy to fast-track generic drug applications where competition for medication is limited. Furthermore, it published a list of off-patent branded medicines for which no generic medications available. Over the course of 2017, the FDA announced 74 first-time generic drug approvals, including generic versions of multiple sclerosis drug Lioresal (baclofen), atopic dermatitis treatment Locoid (hydrocortisone butyrate), and the antidepressant Prozac (fluoxetine).
