1:51 PM
Oct 09, 2018
 |  BC Extra  |  Politics & Policy

FDA pushes generic competition for transdermal complex drugs

FDA clarified how to develop generic versions of transdermal or topical complex drugs, releasing a series of guidances Tuesday as the agency continues its push for greater generics competition.

Complex drugs, especially those with transdermal and topical formulations, often face less competition even after losing exclusivity because of the additional challenges for making generic versions, FDA Commissioner Scott Gottlieb said in a statement.

Providing greater transparency and predictability will allow sponsors to develop generic versions of those drugs more efficiently and submit more complete ANDA submissions, he added.

FDA's guidances include revised draft recommendations for designing trials to evaluate adhesion of proposed generics; new recommendations for designing trials to evaluate in vivo skin irritation and sensitization potential; and 25 product-specific guidances, including two new guidances for capsaicin and estradiol/norethindrone. 
"Any steps we can take to encourage the development of generic competitors for complex drugs may have an outsized impact on access, and drug spending," Gottlieb said.

Gottlieb teased upcoming policies in his statement, including new analytical tools and in vitro tests to show "sameness" between generic and branded versions of complex drugs. FDA will also release guidances for navigating legal barriers to generic competition and clarifying how the agency evaluates different instructions for use of generic versions of complex drugs.

The agency has taken several steps to help generics reach market, including creating a priority ANDA review category, since Gottlieb unveiled a drug competition action plan during a May 2017 congressional appropriations hearing. “Simply put, too many patients are priced out of the medicines they need,” Gottlieb said at the time (see "Gottlieb Seeks More Robust Generic Competition").

Last week, FDA released a draft guidance aimed at reducing the use of 505(q) Citizen's Petitions intended to delay market entry of generic drugs (see "FDA Cracking Down on Use of Petitions to Delay Generics").

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