Administering the Hatch-Waxman Amendments: Industry, Academics and Senator Discuss Balance

Regulatory NewsRegulatory News | 27 November 2017 |  By 

The US Food and Drug Administration (FDA) has made it a priority to find a balance between encouraging innovative medical products and increasing access to lower-cost pharmaceuticals under the Hatch-Waxman Act 1984. But when it comes to finding ways to speed the influx of generic drugs and stop frequently cited abuses, a host of voices from industry, academia and Congress are offering differing views.

In July, FDA held a meeting to discuss certain situations in which brand-name drug companies delay generic competition to an extent that, according to FDA, "may not have been intended by the Hatch-Waxman Amendments, and in ways that may not serve the public health."

For example, innovators have made changes in patent use codes that create obstacles to previously acceptable labeling carve-outs. And restrictions on the distribution of innovator drugs, whether voluntarily adopted by the innovator or imposed as a requirement of FDA regulation, have prevented developers from accessing drug samples needed for testing to support abbreviated new drug applications (ANDAs).

Comments related to the July meeting highlighted further issues.

Latest Comments

The latest batch of comments pits the generic drug industry, represented by the Association for Accessible Medicines (AAM), against the branded drug industry group PhRMA, while others, including Sen. Orrin Hatch (R-UT) and academics from Harvard Medical School’s Program on Regulation, Therapeutics, and Law (PORTAL), weighed in too.

AAM’s comments focused on 14 topics including citizen petitions and other petition process improvements, ANDA labeling carve-outs, complex generics, formulation changes and other regulatory areas that could help increase generic competition.

"Action is needed to restore the Hatch-Waxman balance between encouraging innovation and drug development and accelerating the availability of lower cost generic alternatives. This includes legislative action, such as the CREATES Act, to address brand company abuses. But FDA should also use its existing statutory authority to deter anti-competitive tactics employed by brand companies, streamline and expedite the generic drug approval process, and increase transparency into Agency actions and decisions," AAM said.

PhRMA, meanwhile, focused its comment dated 17 November on "certain areas where incentives for innovation may be insufficient," including data protection and exclusivity periods.

"For example, where a therapeutically equivalent generic product’s labeling does not include one of the reference listed drug’s (RLD’s) indications protected by Hatch-Waxman three-year exclusivity, pharmacists will still automatically substitute the generic version," PhRMA noted. "This is the case even where the patient is taking the drug for treatment of the protected indication, thereby undermining the incentive for the innovator to obtain approval of a new indication. Given the substantial investment required for the studies undertaken to obtain the approvals that lead to three-year exclusivity and the benefit to the public health from such investment, we believe that FDA can, and should, take additional steps to ensure the proper balance between innovation and competition in this context." 

Experts from Harvard’s PORTAL highlighted numerous cases in which branded manufacturers have taken advantage of elements to assure safe use (ETASU) in risk evaluation and mitigation strategies (REMS) to stave off generic competition.

"The FDA could help limit such abuses in three ways," they wrote. "First, the agency could compel sample deposit sufficient for bioequivalence testing by at least three generic manufacturers as a condition of brand-name drug approval. In exchange for sample access, the agency could require a generic manufacturer to commit to marketing its product for a minimum of 5-years in addition to obtaining FDA certification of the safety of its testing protocol (if the drug is subject to an ETASU REMS). Second, the FDA could support passage of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which would authorize generic manufacturers to petition a court to require sale of drug samples if a brand-name manufacturer blocked access, mandate FDA certification of the safety of testing protocols for ETASU REMS-covered drugs, and allow the FDA to approve separate ETASU REMS for generic products. Third, the FDA could also encourage Congress to take measures to prohibit REMS patenting, or at least prevent REMS patents from being listed in the Orange Book."

Hatch, meanwhile, in a letter sent to FDA in September, mentioned instances in the recent past "when the spirit of Hatch-Waxman has been abused and tactics have been used to maintain a stranglehold on a certain class of medications. Reforms to this legislation and the regulations that came about as a result must address these maneuvers that meet the letter of the law but scoff at its intent."

But with regard to REMS abuses, Hatch said, "A balance must be found between encouraging innovation and spurring competition that benefits all stakeholders. REMS exist for a reason, and when we confuse patient-access at all costs with valid safety concerns, we put patient lives at risk."

Hatch also pushed back on an idea, supported by Sen. Bernie Sanders (D-VT), to create more competition through generic drug imports from abroad.

"The importance of FDA's role in ensuring the protection of public health via strict and rigorous safety evaluations of new medications is indispensable. Any change in policy that allows this process to be circumvented, such as the importation of drugs from other countries, would be of grave concern," Hatch wrote.



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