FAST Generics Act of 2015.

Abstract

*Director, Drug Information Group and Prior Authorization Services, Clinical Associate Professor, Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy, Chicago, Illinois In June 2015, the bipartisan Fair Access for Safe and Timely (FAST) Generics Act was reintroduced in the House of Representatives.1 This Act was developed in response to accusations that manufacturers of brand name medications are “abusing restricted access programs” in order to delay the entry of generic products into the pharmaceutical market.2 In 2007, the US Food and Drug Administration (FDA) was given the authority to require a Risk Evaluation and Mitigation Strategy, or REMS, from pharmaceutical manufacturers.3 A REMS is essentially a risk management plan that is developed by the manufacturer, approved by the FDA, and implemented by health care providers. This plan helps providers manage a known or potential serious safety risk associated with a medication and enables patients to have appropriate and safe access to the medication. REMS may involve patient or provider education, medication guides, restricted distribution programs, or required medical interventions or other actions providers need to perform prior to prescribing or dispensing a medication (ie. elements to assure safe use or ETASU). Approximately 40% of all new drug approvals are subject to REMS, and the number of REMS that restrict medication distribution in some manner has increased dramatically over recent years.4 The FAST Generics Act aims to amend the federal Food, Drug, and Cosmetic Act so that “eligible product developers have competitive access to approved drugs and licensed biological products.”5 Basically, passage and approval of the FAST Generics Act would result in the closing of a loophole. This loophole currently allows pharmaceutical manufacturers to utilize aspects of REMS programs, such as restricted distribution networks, to deny generic and biosimilar manufacturers access to samples of brand name reference products. These samples are needed in order for the generic or biosimilar manufacturer to conduct appropriate studies comparing its proposed product to the brand name reference medication for FDA approval.2 In normal situations, obtaining a brand name reference product sample is fairly easy; however, products that are available through a restricted distribution program have access tightly controlled.6 In July 2014, a report on the impact of using REMS programs to delay generic market entry was published by the economic policy consulting firm, Matrix Global Advisors.4 This report, which was sponsored by the Generic Pharmaceutical Association, estimated lost savings on 40 generic smallmolecule products whose market entry was delayed by misuse of REMS or other restricted access programs, according to a survey of generic manufacturers. Specifically, the analysis found that the use of such programs to create barriers for generic competition costs the US health care system an estimated $5.4 billion annually. Passage of the FAST Generics Act is not only meant to be a potential cost-saving measure, but also to engage the Department of Health and Human Services (HHS) as the “go-between” between generic and brand name manufacturers.7 The generic manufacturer would have to receive authorization from HHS prior to requesting a reference product sample from the brand name manufacturer. The Act would also allow for injunctive relief and damages if a generic manufacturer is inappropriately denied access to needed samples. Opponents of the FAST Generics Act focus on the importance of REMS programs with regard to protecting patients from serious harm.1 They note that many of these medications have extensive safety concerns and that the Act may “dilute important safety mechanisms.”7 Opponents also note that the mere existence of a REMS program, even with the more restrictive ETASU requirements, does not eliminate the approval of a generic product. In fact, generic products exist for medications with REMS including medications with ETASU provisions. Hosp Pharm 2016;51(1):42–43 2016 © Thomas Land Publishers, Inc. www.hospital-pharmacy.com doi: 10.1310/hpj5101-42