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FDA In Brief: FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids

July 20, 2018

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  Angela Stark
  301-796-0397

“One way the FDA is taking steps to address rising drug costs for patients is by helping to support the development of high-quality, generic medicines. Generic drugs increase price competition and provide access to more affordable options for consumers,” said FDA Commissioner Scott Gottlieb, M.D. “By publishing guidance describing the FDA’s current thinking on how to develop specific generic drug products, we’re making sure generic drug developers have the most current scientific and regulatory standards to make their development process more predictable and efficient. This is especially important for manufacturers seeking to develop hard-to-copy complex generics, such as drug-device combination products. This includes products where the drugs are incorporated into nasal aerosol devices, for example. These generic products often have features that make them harder to copy and therefore less likely to be developed in the first place. Many complex drugs face little or no generic competition as a result, even though patents and other exclusivities have lapsed on the branded products. We’re also updating certain guidances on the development of generic copies of abuse-deterrent formulations of opioid analgesics. The creation of an efficient path to developing generic versions of opioid analgesics with abuse-deterrent features is important for the development of lower cost, generic versions of drugs with these abuse-deterrent features. The widespread availability of generic abuse-deterrent opioids may help convince providers and payers to switch to these alternatives. These updated guidances will make the process for developing low cost, generic versions of these abuse-deterrent products more predictable and practical. The documents issuing today add to the nearly 1,600 product-specific guidances we’ve published to date across therapeutic classes, ensuring our policies and standards keep pace with the evolving science of equivalence for generics, enabling greater patient access to high-quality, affordable medicines.”

The U.S. Food and Drug Administration today announced a new batch of product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs. The batch contains 43 product-specific guidances, including 26 new guidances and 17 revised guidances that, when finalized, will describe the FDA’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their respective reference-listed drugs.

Ten of the new draft guidances and six of the revised guidances are for complex drug products, including multiple products that don’t yet have generic competition. This batch of guidances also includes three revised product-specific guidances for abuse-deterrent formulations of opioid analgesics.

The FDA believes that increased transparency on product-specific guidances gives manufacturers seeking to develop generic copies of medicines, 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 versions of these complex products so that patients have access to affordable medicines. Greater access to high quality generic drugs is one way the FDA is working to promote access to important medicines and advance the public health.

Related 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.

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