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# Generic Industry Opposes ‘BLOCKING’ Act
- URL: https://www.fdaweb.com/generic-industry-opposes-blocking-act/
- Published: 2019-02-04T12:00:00.000Z
- Updated: 2026-09-15T01:00:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143289

Generic drugs lobbying arm Association for Accessible Medicines (AAM) says it is concerned that new legislation introduced by Congressmen **Kurt Schrader** (D-OR) and **Earl L. Carter** (R-GA) may have the “unintended impact of reducing competition in the prescription drug market and thus lead to patients continuing to pay the high-cost of brand-name drugs for longer.” The lawmakers’ bill, *Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act* ([HR 938](http://www.fdalawblog.net/wp-content/uploads/2019/02/BLOCKING-Act.pdf?ref=fdaweb.com)), would aim to prevent the first generic product makers of a class of drugs “parking” their exclusivity awards and thus blocking subsequent generic approvals ([see earlier story](https://www.fdaweb.com/congressmen-introduce-bill-to-prevent-generic-drug-delays/)).

“While there are many steps Congress could take to increase competition and enhance patient access to more affordable FDA-approved generics and biosimilars, this proposed legislation would have the opposite effect,” an AAM letter to Schrader says. “In fact, it undermines the only incentive provided to generic manufacturers to challenge the patent thickets created by brand-name drug companies.”

The group says that in recent years, generic and biosimilar manufacturers have found it increasingly difficult to bring more affordable medicines to market due to rampant patent abuse. “Of the roughly 100 best-selling brand-name drugs, more than 70% obtained a patent to extend their monopoly beyond the initial 20 years,” the letter says. “Challenging weak or questionable patents is an expensive endeavor without any guarantee of success... In 2017 alone, the top-12 grossing brand-name drugs were granted 71 patents on average for each drug.This level of patent protection delays competition by up to 38 years – well past Congressional intent.”

Instead of addressing the increasing trend of patent abuse by brand-name companies, the BLOCKING Act undermines the only incentive generic manufacturers have to challenge patent abuse, AAM says. “Weakening the 180-day period of exclusivity for first generics ensures more weak and questionable patents stay in place, delaying the entry of generic medicines into the market,” it says. “As a result, patients will continue to pay the high price of brand-name drugs without competition from more affordable FDA-approved generic medicine. Moreover, no evidence has been provided to date to justify changes to the 180-day exclusivity for first generics.”

AAM also notes that if FDA concludes that a first applicant is not actively pursuing approval of its ANDA, it may immediately approve an ANDA of a subsequent applicant if it is ready for approval. “We strongly encourage Congressional efforts be focused on what’s driving prescription drug prices to be out of reach for too many patients, such as abuse of the patent system...,” the group adds.