REMS Abuse Stifling Generic Competition, Increasing Drug Costs

Published Online: Tuesday, August 5, 2014
Follow Pharmacy_Times:

A report released by the Generic Pharmaceutical Association (GPhA) on July 23, 2014, finds that abuse of FDA drug safety programs to prevent generic competition has delayed the arrival of 40 potential generic drugs, costing patients $5.4 billion annually. 

The report, conducted by Matrix Global Advisors, finds that risk evaluation and mitigation strategies (REMS), originally established to prevent the misuse of high-risk prescription medications, are being used by drug companies to limit generic competition by denying generic firms access to product samples needed to develop new generic versions of medications. The researchers of the report calculated the cost of REMS and other restricted-access program abuse for the health care system and patients. 

Of the total $5.4 billion in annual costs associated with REMS abuse, the federal government lost $1.8 billion, private insurers lost $2.4 billion, and consumers paid $960 million extra in out-of-pocket pharmaceutical costs. The report also estimated that after biosimilars enter the market, the misuse of REMS and other programs would result in approximately $140 million in lost savings for every $1 billion in biologic sales.

“For patients waiting for generic alternatives to expensive brand medicines, every day counts. For lawmakers struggling to balance the budget, every dollar matters,” said Ralph G. Neas, GPhA president and CEO, in a press release. “This study shows that by using safety programs as a smokescreen for anticompetitive practices, some brand companies are delaying generic choices for patients and driving up drug costs.”



Related Articles
GPhA has agreed to support compromise automatic substitution legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. This step brings millions of Americans closer to the day when they will be able to access safe alternatives to costly biologic medicines. Indeed, Express Scripts projects savings of $250 billion in 10 years should only the 11 likeliest biosimilars enter the market.
Pharmacists will play key role in bringing biosimilar medications to US markets, both before the therapies receive FDA approval and after they become available.
Baxter International has submitted a biologics license application to the FDA for its investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on antihemophilic factor.
A diverse collective of health care advocacy groups, patient organizations, industry representatives and other stakeholders today announced they have established the Alliance for Balanced Pain Management to support appropriate access to integrated pain management and responsible use of prescription pain medicines with an aim to reduce abuse. AfBPM will work collaboratively to educate, support and advocate on behalf of people affected by pain, both acute and chronic.
Latest Issues
$auto_registration$