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# Waxman-Hatch at Risk: Analysis
- URL: https://www.fdaweb.com/waxman-hatch-at-risk-analysis/
- Published: 2019-12-10T12:00:00.000Z
- Updated: 2026-09-14T15:56:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145688

Attorney **Kurt Karst** (Hyman, Phelps & McNamara) says Congress may be readying a “significant blow” to the Waxman-Hatch Act and the generic drug industry through passage of the Lower Health Care Costs Act of 2019\. In a [post](http://www.fdalawblog.net/2019/12/is-congress-poised-to-deal-a-significant-blow-to-hatch-waxman-and-the-generic-drug-industry/?ref=fdaweb.com) in his firm’s *FDA Law Blog*, Karst says the bipartisan, bicameral bill contains several FDA-related provisions, such as *Orange Book* and *Purple Book* modernization, orphan drugs, biosimilars, and exclusivity for first-to-file generic drug applicants.

Included in the bill, he says, is language from H.R. 918, the Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (the BLOCKING Act).

According to Karst, the BLOCKING Act would punish ANDA applicants eligible for 180-day exclusivity who are diligently pursuing final application approval and would “further dilute and cheapen the 180-day exclusivity incentive Congress created in the 1984 Waxman-Hatch amendments.”

In particular, Karst writes, the BLOCKING Act could trigger a loss of exclusivity, even when the generic drug applicant is diligently seeking final approval, based on a failure of FDA to grant final approval to a first applicant within 30 months of application submission for any reason.

The Association for Accessible Medicines (AAM), which represents generic drug companies, [says](https://accessiblemeds.org/resources/press-releases/aam-opposes-lower-health-care-costs-act?ref=fdaweb.com) it opposes the Lower Health Care Costs Act because of the BLOCKING provisions that “will reduce generic drug competition, result in fewer affordable generic medicines being available to patients, and thus will keep drug prices high.” The association says it has offered numerous alternatives to the BLOCKING provisions.

A forthcoming study by Matrix Global Advisors finds that by creating a risk that first filers could lose their exclusivity the BLOCKING Act would reduce generic firms’ incentives to pursue patent challenges, thus delaying generic entry and savings, AAM says.

“Unfortunately, inclusion of the BLOCKING Act will eviscerate the single most successful incentive available to generic drug developers to bring new, more affordable generic medicines to patients,” AAM says. “The 180-day incentive encourages generic drug manufacturers to take on the costs and risks associated with challenging brand-name drug patents. Without this incentive, the substantial savings resulting from generic competition — a hallmark of the successful Waxman-Hatch amendments in place for decades — will be jeopardized.”