FDA Reform Act Signed into Law
A Victory for the American People
In a major victory for the American people, President Obama recently signed into law the U.S. Food and Drug Administration's Safety and Innovation Act that will allow the U.S. government to speed approval of lifesaving medicines, reduce drug shortages and improve the quality and availability of drugs in the U.S.
The new law includes authorization of the Generic Drug User Fee Act (GDUFA), which will level the playing field and improve the drug supply chain by requiring inspection of all foreign and domestic drug production facilities. Domestic pharmaceutical companies are inspected every two to three years by the FDA, but most of their foreign counterparts have never been inspected by the FDA.
Up to 40 % of all drugs Americans take are imported, according to the U.S. Government Accountability Office (GAO), and about 80 % of the active pharmaceutical ingredients in those drugs come from foreign sources. Passage of the bill was a key step in safeguarding the U.S. drug supply by ensuring greater scrutiny of drug manufacturing in high-risk regions of the world.
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA) that has since 2006 advocated for increased resources for the FDA to conduct these inspections, hailed the signing of the bill, calling it a turning point in the fight to eliminate contaminated or counterfeit drug products from consumer shelves.
"For too long, the U.S. drug supply has been susceptible to sub-par quality drugs due to the lack of FDA enforcement of basic drug quality inspections of foreign facilities," said BPTF Chair Patty Benson, Quality Assurance Director of SAFC. "By signing this bipartisan, bicameral bill into law, the President has demonstrated his commitment to improving the quality of drugs entering the U.S. and encouraging domestic job production by eliminating the economic advantage of foreign manufacturing facilities."
As an organization focused on advancing drug safety, BPTF is a key stakeholder that worked with other industry groups last year to negotiate the terms included in GDUFA. BPTF members are among those who will pay nearly $1.5 billion over the course of five years to accomplish the goals of GDUFA and more. With company budgets tight and economic uncertainty at an all-time high, these generic drug producers voluntarily agreed to pay these fees in order to avoid another heparin-like tragedy.
BPTF's goals of holding all players contributing to the U.S. generic drug system to the same inspection standards and enhancing the agency's ability to identify and track registration and contributors involved in each drug product sold in the U.S. are encompassed in the new law, which was overwhelmingly passed by both the U.S. House of Representatives and the U.S. Senate in May.
GDUFA will expedite the availability of more affordable, high-quality generic drugs. It will provide the FDA, which previously had been unable to accurately identify all foreign facilities manufacturing drugs entering the U.S., with the resources to create a system to track these facilities for the purpose of quality inspections.
GDUFA will also enhance the FDA's ability to prevent substandard and misbranded drugs from entering the supply chain. Significantly, the legislation also authorizes FDA to confiscate and destroy counterfeit, adulterated or misbranded drugs that reach U.S. borders rather than returning them to foreign manufacturers. Past practices forced the FDA to send the drugs back to their country of origin, where they were ultimately returned to the drug supply chain in other countries.
The new law will be implemented in stages over the course of the next few years and will only succeed through the diligence of all stakeholders, according to BPTF.
SOCMA Society of Chemical
1850 M Street NW, Suite 700
Washington, DC 20036-5810
+1 202 2968560
+1 202 2968120