FDA acts to encourage generic competition for complex drugs

FILE - In this Wednesday, April 5, 2017, file photo, Dr. Scott Gottlieb speaks during his confirmation hearing before a Senate committee, in Washington, as President Donald Trump's nominee to head the Food and Drug Administration. On Monday, Oct. 2, 2017, FDA Commissioner Gottlieb said the administration is opening a new front in its efforts to reduce high drug prices by increasing competition, focusing on medicines so complex to make that they don't face generic competition promptly, if ever. (AP Photo/J. Scott Applewhite, File)

TRENTON, N.J. — The U.S. Food and Drug Administration is opening a new front in its efforts to reduce high drug prices by encouraging development of generic versions of hard-to-make medicines.

Complex drugs and drug-device combinations generally are very expensive and some are widely used. Often, they don't get generic competition right after their patent expires, as happens routinely with pills.

Difficulty in creating copies or near-copies of such drugs and getting them approved may deter generic companies from even trying, FDA Commissioner Dr. Scott Gottlieb wrote in a blog post.

That means patients don't get access to cheaper versions of those drugs and the brand-name medicine makers continue to rake in money, often billions of dollars a year per drug.

To get more generic versions of complex drugs on the market, the FDA will begin giving companies guidance on how to win approvals, including offering meetings with agency staff early on, to shorten the time for development and approval.

Examples of older complex drugs cited by Gottlieb that still lack generic competition include the Advair inhaler and injected medicines Forteo for osteoporosis, Victoza for high blood sugar and Copaxone for multiple sclerosis.

Their monthly costs without insurance range from about $400 for Advair to up to $5,200 for Copaxone. A generic version of Copaxone was approved in 2015, but it's not yet on sale because the maker hasn't met FDA's manufacturing standards.

"This is a shot across the bow" to the brand-name companies, said analyst Steve Brozak, president of WBB Securities.

Gottlieb's close ties to drugmakers worried consumer groups when he was nominated. Now, Brozak said, he's telling brand-name drugmakers to focus on developing new drugs, not wringing extra money out of blockbusters long on the market, while encouraging generic makers.

"Nothing in health care is instantaneous," Brozak said, but Gottlieb "is starting to build a road map for how to prove" a generic is equivalent to a complex brand-name drug.

Longer-term plans include coming up with new, better tools to determine if a proposed copycat of a complex injected drug really will affect patients the same way.

The FDA has already made changes to increase competition including reducing a backlog of generic pills that were awaiting approval and addressing some loopholes brand-name makers use to delay competition.

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Follow Linda A. Johnson at @LindaJ_onPharma.

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