Patient Advocates Press Congress To Preserve The Integrity Of The Nation's Drug Safety System

Washington, DC /PRNewswire-USNewswire/ -- Almost a decade after the U.S. Congress gave the Food and Drug Administration (FDA) authority to require Risk Evaluation and Mitigation Strategies (REMS) for higher risk medicines, 16 public health, patient advocacy, health professional, and disease organizations are raising concerns that proposed legislation will weaken these drug safety protections and make it easier for potentially dangerous drugs to get into the wrong hands.

In a joint letter addressed to the Senate Judiciary Committee, supporters and members of the Patients' Alliance for Drug Safety Protections (Patients' Alliance) cautioned lawmakers that the recently introduced Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 (S. 3056) will significantly curtail FDA's authority to regulate high-risk drugs, including medicines that can cause severe birth defects, organ damage and even death when not carefully controlled.  While supporting the goal of the CREATES Act – to speed the development of less expensive generic drugs – the advocates expressed "significant misgivings" that as proposed, the bill will force the sale of medicines carrying serious risks to generic marketers for comparison testing while doing away with established procedures that ensure generic manufacturers adopt the same safety protocols when testing these drugs in human subjects, as well as permit separate generic REMS of unproven safety, without stakeholder input. 

"The Society for Women's Health Research (SWHR®) has long recognized the importance of lower-cost generic drugs to patients and the health care system. However, we also recognize that stringent REMS requirements are essential so that patients can have safe access to powerful drugs that offer life-saving benefits but come with high risks.  This is why it is imperative that generic manufacturers be held to the same safety requirements when testing drugs that are subject to REMS controls, and cannot have separate REMS of unproven safety" said Larry Hausner, SWHR's interim president and CEO. "Because studies on generic drugs are conducted in human subjects and creating separate REMS requires a demonstration of equivalent safety, there can be very real consequences to public health and safety if these medicines are not carefully controlled."

Speaking for the millions of Americans with serious diseases like cancer, kidney disease, and multiple sclerosis who currently benefit from medicines marketed with REMS safety measures, the joint letter stressed the need for stringent REMS safety precautions called "Elements to Assure Safe Use" (ETASU) and especially restricted distribution programs that prevent harmful exposure to medicines when there is no room for error. Currently, there are about 40 REMS with FDA-mandated restricted distribution system due to their inherent toxicity or potential harmfulness. This includes a number of drugs known to cause severe birth defects in the infants of pregnant women, unless there are rigorous controls to prevent unsafe exposure.

Because REMS safeguards prevent drug diversion and make it possible for FDA to approve valuable medications that would otherwise not be on the market the joint letter urges legislators to "act with an abundance of caution" when considering provisions of the CREATES Act that that would weaken FDA's oversight of the REMS program and create disincentives for the future development and marketing of higher-risk drugs, especially to treat rare disorders, due to liability concerns.  

Of key concern to the drug safety advocates are provisions that would:

• Eliminate established procedures whereby FDA ensures both innovator and generic manufacturers are held to the same safety requirements when testing potentially dangerous drugs
• Limit FDA's authorization process for how generic companies obtain samples for clinical testing
• Curtail the methods the agency now uses to verify a generic developer has the safety track record and capability to follow a rigorous risk management system
• Not require evidence demonstrating that separate REMS will ensure the same level of safety, and permit unproven generic REMS approvals behind closed doors without stakeholder input 
• Allow generic manufacturers to attest to the rigor of their risk management program instead of requiring the companies to submit detailed documentation that is reviewed and approved by FDA

"Although the goal of speeding the development of less expensive generic medicines and biosimilars is laudable, we urge legislators to act with an abundance of caution when considering proposals such as the CREATES Act. If the current system is changed, then it must include a robust FDA process that goes beyond reviewing self-attestations form and includes a review of a product developer's actual capabilities and its safety history," the letter states.

The joint letter, sent on (date) to the leaders of the Senate Judiciary Committee's Subcommittee on Antitrust, Competition Policy and Consumer Rights – Senators Patrick Leahy (D-Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) –represents the views of the following organizations: the Alliance for the Adoption of Innovations in Medicine (Aimed Alliance), American Autoimmune Related Disease Association (AARDA), Association of Women's Health, Obstetric and Neonatal Nurses (AWHON), C-Change, Consortium of MS Centers, Center for Lawful Access and Abuse Deterrence (CLAAD), Cutaneous Lymphoma Foundation, HealthyWomen, International Myeloma Foundation (IMF), March of Dimes, Myelodysplastic Syndrome Foundation (MDS Foundation), National Association of Nurse Practitioners in Women's Health (NPWH), OTIS/MotherToBaby, Patients Rising, Society for Women's Health Research (SWHR), and Teratology Society.

About the Patients Alliance for Drug Safety Protections
Formed in 2015 and spearheaded by the Society for Women's Health Research, the Patients Alliance for Drug Safety Protections (Patients' Alliance) is a coalition of national public health, patient advocacy, health professional and disease organizations working collaboratively to raise awareness of the importance of REMS as a tool to advance patient safety and protect public health. Click here to learn more about the Patients' Alliance.