What To Watch As FDA Begins To Fight Rising Drug Prices

August 4, 2017 Published Work
Law360, New York

With the enactment of the Hatch-Waxman Act, Congress spurred generic competitors to enter the market and lower the cost of expensive, brand-name pharmaceuticals. At the same time, to incentivize new drug development, the act provides limited regulatory exclusivity periods for drug innovators.[1] As a product's market exclusivity period wanes, drug innovators may use creative and sometimes controversial means to maintain dominance in the market and keep products free from generic competition. These anti-competitive tactics trigger the involvement of the Federal Trade Commission, but until now, the issue has not similarly stirred the U.S. Food and Drug Administration to action.

As of last month, the FDA's reluctance to engage in price-control efforts may be changing. On July 18, the FDA held a public meeting to solicit input on how it might join the fray.[2]

We now take a look at some of the controversial issues that frequently arise incident to Hatch-Waxman that the FDA may set its sights on in the near future.

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[1] 21 C.F.R. §§ 314.108, 316.31, 316.34; Food Drug and Cosmetic Act, 21 U.S.C. §§ 505A-E, 505(j)(5)(B)(iv).

[2] Press Release, FDA Working to Lift Barriers to Generic Drug Competition, Food & Drug Admin. (June 21, 2017).