FDA releases generics guidances to encourage competition

Product-specific guidances are issued by regulatory bodies to ensure that generics are pharmaceutically equivalent to their reference listed drug and that the two drugs have the same safety and efficacy. These reports are used in the development of generic versions of brand name drugs.

Generic drugs must have the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug.

The most recent posting contains 57 product-specific guidances─35 new and 22 revised. Fifteen of the new draft guidances and four of the revised guidances are for complex drug products, including multiple products that do not yet have generic competition.

This follows a report by the GAO that accused the FDA of failing to issue product-specific guidance documents and recommended that the agency announce its plans to issue and revise guidance for complex drugs.

The newest product-specific guidances include guidances for Pfizer’s eczema drug Eucrisa and Clovis Oncology’s PARP therapy Rubraca. They may facilitate the development of cheaper generic alternatives to these complex drugs.

FDA commissioner Scott Gottlieb said: “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 ‘genericise,’ 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.”

In a statement, the agency said that it would continue to routinely post and revise product-specific guidances.

In June 2017, the FDA launched a Drug Competition Action Plan to improve patient access through the development of generic drugs in pharmaceutical categories that lacked competition. This particularly focused on ‘complex’ drugs, which are drugs that involve a complex formulation or complex active ingredient, thus making it harder to develop a generic equivalent. Increased transparency in the publication of product-specific guidances may encourage further competition and greater public access to cheaper generic drugs.

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