Statement from Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association on Recent Changes at FDA Office of Generic Drugs

Published Online: Thursday, March 14, 2013
Follow Pharmacy_Times:
PRESS RELEASE

WASHINGTON, DC (March 14, 2013) — GPhA was disappointed to learn of Dr. Gregory Geba’s departure from the FDA’s Office of Generic Drugs (OGD). Today, 80% of prescriptions dispensed in America are generics. GPhA and its member companies rely on the strength and continuity of the OGD on critical matters such as regulations governing the entry to market of new, cost-saving generic versions of critical medicines, and the implementation of the GDUFA process.

As FDA Commissioner Margaret Hamburg said recently at the GPhA 2013 Annual Meeting, “There are few American households who have not benefited from the success of the generic drug industry. [The generic industry’s] task and our task is ensuring that the medications that these millions of Americans take every day are safe, effective and of high quality.”

We believe accomplishing this task requires a reliable, consistent, and properly-staffed regulatory partner. From 2010 to 2012, the Office of Generic Drugs had no leadership. Now, with Dr. Geba’s departure, we are significantly concerned about further disruption at the FDA. These vacancies and changes hold the potential to distract from the critical mission of the OGD, and slow the flow of information, guidance, and approvals needed to achieve an optimal generic drugs market for patients, payors, and the health care system.

We trust that FDA is doing everything possible to ensure that the Office of Generic Drugs is fully staffed so that it can continue its regulatory mandate and GDUFA implementation. We look forward to working with Dr. Janet Woodcock and others to strengthen OGD and ensure that patients have reliable access to safe and affordable generic medicines.

Related Articles
The Generic Pharmaceutical Association welcomes the FDA’s proposed rule to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for healthcare professionals.
The Generic Pharmaceutical Association has serious concerns about the unbalanced structure of the Trans-Pacific Partnership agreement in its current form.
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.
“GPhA applauds FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse Risk Evaluation and Mitigation Strategies programs to thwart competition from more affordable generic drugs. The ongoing abuse of REMS and REMS-like programs costs the American health system and its patients $5.4 billion annually, according to a study conducted by Matrix Global Advisors. Interestingly, as the United States market readies for biosimilars, this same study identifies $140 million in lost savings that would occur for every $1 billion in biologics sales.
Latest Issues
$auto_registration$