FDA In Brief: FDA issues 57 product-specific guidances, including 19 laying out path for developing generics to hard-to-copy “complex” medicines

Feb. 8, 2018

Media Inquiries

“Since becoming Commissioner I’ve made it my goal to improve patient access to affordable drugs. No patient should be priced out of critical medicine. It’s a public health concern if patients can’t access the drugs they need. It’s an issue we’re addressing using the full scope of our authorities. As part of this commitment, we’re advancing many policies aimed at making it easier to bring safe, effective, high-quality generic competition to the market, especially for a category of branded medicines known as “complex drugs.” These drugs are often harder to “genericize,” or copy, under our traditional approaches. In too many cases, that has discouraged competition. It’s meant branded drugs have enjoyed monopolies long after their patents and exclusivities have lapsed,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA has long recognized the need to support the development and approval of complex generics, including the regulatory science underlying these drug products. Today, we’re providing the generic drug industry with 57 total product-specific guidances, many for drugs that don’t yet have generic competition, to help industry identify the most appropriate methodology for generating evidence needed to support approval of generic drug applications. To date, we’ve now published about 1,600 of these product-specific guidances laying out the path for developing generics to specific products; including more than 350 guidances for developing generics of complex drugs.”

The FDA believes that increased transparency on product-specific recommendations gives manufacturers seeking to develop generic copies of complex drugs a better opportunity to efficiently allocate resources. The agency aims to make sure that policies and regulations – and scientific and clinical standards – keep pace with the evolving science around developing generic versions of these complex products so that patients have access to affordable medicines. Greater access to high quality generic drugs is key to giving us more ways to advance the public health.

Today’s posting contains 57 product-specific guidances, including 35 new guidances and 22 revised guidances. Fifteen of the new draft guidances and four of the revised guidances are for complex drug products, including multiple products that don’t yet have generic competition. The agency will continue to routinely post and revise product-specific guidances.

The issuance of product-specific guidances aligns with the recommendations recently made by the Government Accountability Office’s report, “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contained a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. The agency agrees with GAO’s recommendation and is actively working to accomplish this goal through new policies that are already underway.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.