by Steven Lucio
PharmD, BCPS, Associate Vice President, Pharmacy Services


Given the challenge of achieving agreement on any issue in Washington, D.C., especially on topics involving health care, we should pause and celebrate situations where bipartisan behavior may be taking hold.

Such is the case with a piece of legislation recently introduced: H.R.2051, the Fair Access for Safe and Timely (FAST) Generics Act of 2017. This bill is aimed squarely at improving the process by which competing medications (generics or biosimilars) are developed to address two critical issues to pharmacy practice: tenuous and interrupted product availability and exorbitant price increases for sole source, legacy medications.

While this legislation would not remediate every issue associated with drug shortages and high costs, pharmacy practitioners should monitor its progress as well as the progress of other legislative efforts designed to address critical challenges that affect costs and patient care.

H.R.2051 removes unintended barriers to competition

As we have seen over the 30 years generic medications have been in the market, competition following loss of exclusivity for branded pharmaceuticals helps decrease drug costs. This paradigm has yielded an estimated $1.46 trillion in savings from generic drugs between 2006 and 2015.

The hope is similar value will begin to accrue for biologics now that we have entered the era of biosimilars. However, in order to develop and receive approval for competition, developers must either demonstrate bioequivalence (for generics) or high similarity (for biosimilars) as compared to their branded counterparts. Completion of this task necessitates availability of the branded product.

What happens if a generic or biosimilar developer cannot obtain access to the originator medication due to a limited or restricted distribution program for that product? Such is the issue the FAST Generics Act attempts to address.

The concept and impact of limited distribution medications became more prevalent following the 2007 enactment of the U.S. Food and Drug Administration (FDA) Amendments Act (FDAAA). In addition to reauthorizing the prescription drug user fee program, FDAAA granted the FDA authority to establish Risk Evaluation and Medication Strategies (REMS) as a requirement to manage safety considerations for certain licensed pharmaceuticals. One of the strategies the FDA can employ is the requirement for specific Elements to Assure Safe Use (ETASU), which can include limiting the authority to distribute and/or obtain medications to specially trained or specifically designated organizations. This process has enabled the FDA to approve medications that might otherwise not have been endorsed for licensing due to safety concerns.

However, REMS requirements have also presented a barrier to competition. First, competing manufacturers are generally not on the list of those authorized to obtain a REMS medication with ETASU limited distribution requirements. In addition, some suppliers have instituted a voluntary restricted distribution network, not based upon a requirement by the FDA, but as a deliberate strategy to impede generic drug development.

The purpose of the FAST Generics Act is to prevent originator manufacturers from restricting access to branded products needed for the development of generics or biosimilars. In addition, the legislation defines procedures and timeframes by which a generic or biosimilar manufacturer can obtain access to the originator’s pharmaceutical for the purposes of testing.

Vizient advocacy efforts

Both through its industry trade alliance, the Healthcare Supply Chain Association (HSCA) and independently, Vizient has expressed its support for this legislation through letters to the sponsors for this bill, Rep. Peter Welch (D-Vermont) and Rep. David McKinley (R-WV). Those letters can be viewed here and here.

Vizient continues to support the increased introduction of both generics and biosimilars to address the challenges of drug shortages and price increases. No strategy alone will remedy all challenges that confront the supply of pharmaceuticals. However, consistent support for meaningful legislative changes provides the opportunity to address the forces that contribute to the challenges we currently face. For more information about Vizient advocacy efforts, click here.

About the author. In his role at Vizient, Lucio guides member organizations in their efforts with various clinical practice topics, including improving medication safety, mitigating the impact of drug shortages, benchmarking pharmacy costs for key drug classes, evaluating the expense of high-cost biologics and preparing for the future development of biosimilar medications. A subject matter expert in the field of biosimilars, Lucio is lead author of a recently published peer-reviewed article on the topic, he is an active speaker and panel moderator and has presented his insight on biosimilars more than a dozen times in the past year.

Published: April 18, 2017