Washington, D.C.  – Today, Congressman John D. Dingell (D-MI15) issued the following statement regarding the Generic Drug User Fee Act (GDUFA) proposed program recommendations that were released yesterday.

“The Generic Drug User Fee Act is a landmark program that once approved by Congress will speed access to affordable high-quality generic drugs for Americans while at the same time improving the quality, safety and reliability of our nation’s drug supply,” said Dingell.  “This Act will also bring greater transparency to the identification of drug manufacturing facilities, which has become increasingly complex in today’s globalized marketplace.”
 
Today, nearly 40 percent of all the prescription drugs Americans take are imported, and up to 80 percent of the active pharmaceutical ingredients (API) in those drugs come from foreign sources.  Last year, the Government Accountability Office (GAO) reported that the FDA was able to inspect only 11 percent of the foreign establishments in its database, compared to 40 percent of domestic establishments it inspected.  In addition, while the Food, Drug and Cosmetic Act (FDCA) of 1938 requires American drug manufacturers to undergo Good Manufacturing Practice (GMP) surveillance inspections every two years, the Act does not require the same of foreign facilities. 

By providing additional funding to FDA via industry user fees, GDUFA will help close this safety and quality gap by instituting program goals that will require parity in GMP surveillance inspections for both domestic and foreign manufacturers, ensuring that all industry participants in the U.S. generic drug system are held to consistent good manufacturing practice (GMP) standards using a risk-based approach.  Also, through this same system, GDUFA will enhance the FDA’s ability to track registration of all contributors to generic drug products sold in the U.S. and will help reduce disruptions in the pharmaceutical supply chain that frequently lead to drug shortages of important medicines Americans rely on every day. 

The industry fees called for under GDUFA are not expected to add significantly to the cost of generic drugs, so American consumers will continue to receive significant cost benefits that within the last decade have provided more than $931 billion in savings to the nation’s health care system.

“GDUFA is the product of a breakthrough agreement between the FDA and the generic drug industry, and I urge my colleagues on both sides of the aisle to support it,” Dingell continued.  

“Unlike the brand drug industry whose user fee program (the Prescription Drug User Fee Act) is only focused on inspections conducted prior to product approval, the generic drug industry has stepped up to the plate to support routine biennial GMP surveillance inspections on a risk basis for all facilities manufacturing generic drug product for  the U.S. market. 

“Now that the generic drug industry has done its part, Congress must also take this good work one very important step further, and update the Food, Drug & Cosmetic Act of 1938 to adequately reflect the global pharmaceutical world we live in today.  As the law’s pharmaceutical inspection component is currently written, American consumers have no guarantee that the drugs they are taking are safe and manufactured in accordance with FDA’s high quality standards, and U.S. manufacturers are disadvantaged by an unlevel playing field and are held to a higher standard (with associated higher costs) than their foreign counterparts whose products are dispensed in the U.S without routine GMP surveillance inspections.  GDUFA is a significant achievement, but to be truly successful in our efforts to strengthen consumer safety and secure American jobs at home, Congress must also modernize the law that governs the U.S. supply chain, and I will be active in asking my colleagues to do just that.  GDUFA presents us with an opportunity for significant drug safety progress that we cannot afford to miss.”

Congressman Dingell has been a longtime advocate of ensuring the quality of drugs in our Nation’s supply chain. This past April the Congressman introduced legislation that would provide FDA with the authorities and resources it needs to hold foreign manufacturers to the same safety and efficacy standards as domestic companies.  You can read more about H.R. 1483, the Drug Safety Enhancement Act, here.
 

###