February 22, 2019
“As the FDA works to help promote drug competition and patient access to affordable medicines, our efforts have been especially focused on complex drugs, which may be harder to genericize and often face less competition. In 2019, the agency will continue to advance policies to help promote competition in this space and help to reduce development time for complex generics,” said FDA Commissioner Scott Gottlieb, M.D. “One of the ways the FDA can make the process for developing generics, both complex and otherwise, more efficient is through product-specific guidances. Today, the FDA is releasing 74 product-specific guidances. Of these, 49 are for complex drugs, including 16 complex drugs for which there are no approved generics. Complex drug products provide important therapies to patients, they are also important to the economic stability of the generic drug industry overall and will ultimately help to increase patient access to high-quality, safe and affordable medicines. These product-specific guidances build upon our other efforts to increase transparency around products where competition is lacking, such as our work to enhance the utility of the Orange Book, as well as frequent updates of the new off-patent/off-exclusivity list, so that companies can tailor their development programs with a greater understanding of the market dynamics and opportunities.”
The U.S. Food and Drug Administration today announced a new set of product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs. The batch contains 74 product-specific guidances, including 22 new guidances and 52 revised guidances that, when finalized, will describe the FDA’s current thinking and recommendations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs. With today’s batch of guidances, the FDA has issued more than 1,650 product-specific guidances since 2007.
Of the guidances issued today, four are new draft guidances and 45 are revised guidances for complex drug products, including 16 complex products that, to date, do not have approved generics. In total, 35 of the guidances are for drug products without any approved generics. The majority of the revised guidances were updated to include information on data standards formatting for clinical endpoint bioequivalence studies to align with Clinical Interchange Standards Consortium standards.
The FDA believes that increased transparency on product-specific guidances gives manufacturers seeking to develop generic drug products, including complex drugs, a better opportunity to efficiently allocate drug development resources. The agency aims to make sure that its policies and regulations – and scientific standards – keep pace with the evolving science around developing generic complex drug products so that patients have access to affordable medicines. Addressing these challenges and promoting more generic competition to complex medicines is a key part of our Drug Competition Action Plan and our efforts to help promote patient access and lower drug prices.
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.