July 19, 2017
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FDA hosts public forum on reform for generics regulations, approvals

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To ensure the intended balance between encouraging innovation in drug development and accelerating the availability of lower cost alternatives to innovator drugs, the FDA held a forum to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments.

“In too many places people cannot afford the medicines that they need,” Scott Gottlieb, MD, FDA Commissioner, said during his opening remarks. “We have a system that supports market-based pricing for innovation as a way to provide proper incentives to entrepreneurs for taking on the uncertainty of these costly and high-risk endeavors. But that means we also have to have a system that allows for vigorous competition once patent rights have lapsed on these conventions.”

According to Gottlieb, the FDA has already taken steps to address some of these issues as part of the agency’s ongoing Drug Competition Action Plan.

The plan has three key elements:

1. Find areas in which current FDA regulations are misused.

2. Find areas in which obstacles exist for generic medicines.

3. Improve the agency’s generic drug approval process.

Gottlieb said that by the end of 2017, the FDA will develop and issue key documents, such as an Abbreviated New Drug Application practice map, to improve transparency; improve the efficiency of the review and approval system; and increase staff and training to promote professional growth within the agency.

“We here at the FDA believe in innovation,” Janet Woodcock, FDA Center Director, said. “The FDA has a lot of expedited pathways ... that are intended to help promising therapies get into the hand of doctors and patients as quickly as possible. These include things such as the breakthrough designation fast track [and the] accelerated approval priority review.”

Patent exclusivity

According to Michael A. Carrier, JD, professor of law at Rutgers University School of Law, Camden, New Jersey, the Hatch-Waxman’s 180-day exclusivity has “morphed” from an incentive to challenge patents into a tool for brand firms to pay first-filing generics to delay market entry.

During the presentations, the reform of the FDA’s Risk Evaluation and Mitigation Strategies (REMS) was a recurrent topic, ranging from promotion of shared REMS negotiation to a move for Congress to prohibit REMS patenting altogether. Carrier stated that in cases in which a brand might attempt to use the shared REMS process to delay a generic alternative from entering the market, the FDA could allow for quicker approval of waivers.

The FDA recently released a list of drugs that are currently off-patent and off-exclusivity without approved generics along with a manual of policies and procedures for abbreviated new drug applications to begin expediting the approval of new generic products.

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Policy changes

Todd Ebert, president and CEO of Healthcare Supply Chain Association (HSCA), presented a concise set of administrative- and policy-based solutions to decrease the loss in the health care market, gathered from consumers, members of the HSCA and pharmacists:

1. Provide priority review for abbreviated new drug applications for which there are three or fewer alternatives on the market, which Ebert applauded the FDA for recently taking on as an initiative.

2. Implement more specific timelines for expedited reviews — to which Ebert recommended a timeline of 8 months over the current 10-month standard.

3. Use the agency’s authority to fast-track injectable drugs that have limited competition, as the nature of generic injectables requires vigorously maintained processes.

Several presenters stated their concern regarding drug naming policies, including biosimilars in the discussion of generics. Bruce A. Leicher, senior vice president and general counsel of Momenta Pharmaceuticals, advocated for the implementation of a “proper name policy,” in which biosimilars would no longer be required to contain suffixes, whereas originator products do not. “This is very confusing to physicians and patients and creates a barrier to biosimilar adoption by suggesting biosimilars are different,” Leicher said. “This policy must be fixed to apply equally to all biologics, as intended.”

Market pricing

Concerning costs, both Marissa Schlaifer, MS, RPh, consultant pharmacist for Pharmaceutical Care Management Association, and Chester Davis Jr., president and CEO of the Association for Accessible Medicines, provided some statistics. According to Schlaifer, a recent report from the Federal Trade Commission estimated that anticompetitive pay-for-delay deals cost consumers and taxpayers $3 billion to $5 billion every year.

Davis stated in his presentation that when there are three to four generics in a drug class, the net effect produced by the availability of those alternatives produces significant savings for patients, employers and insurers, yet drug manufacturers still deny samples of biologics to other drug developers. “It is becoming clear, if not abundantly clear, that the refusal to provide samples has become primarily about one thing only — that is preventing competition,” Davis concluded.

“Generic drug companies usually need 1,500 to 3,000 doses of the originator drug to use for testing,” Jack Mitchell, director of government relations at the National Center for Health Research said. “Companies are using regulatory strategies to deliberately block access to these needed testing samples. This is especially important since the most expensive branded drugs are making healthcare greatly unaffordable for patients and consumers.”

Mitchell reiterated comments from earlier presenters, stating that besides limiting testing samples, branded companies may be using single REMS as a way to block generic entry. He expressed concern about the various mechanisms that have been used to extend patent protection on drugs. “These mechanisms have ended up increasing, not reducing, cost of treatments and provided relatively little benefit regarding access to the safe and effective and affordable treatments available for patients included children and patients with rare diseases,” Mitchell concluded. – by Talitha Bennett

Reference: FDA. Administering the Hatch-Waxman Amendments: Ensuring a balance between innovation and access; public meeting [webcast]. July 18, 2017. https://www.fda.gov/Drugs/NewsEvents/ucm563986.htm. Accessed July 18, 2017.