Thursday, December 15, 2011
The Generic Pharmaceutical Association (GPhA) expressed its strong support for the recently negotiated Generic Drug User Fee Act (GDUFA). Under the program, which now requires Congressional approval, the FDA will receive nearly $1.5 billion over 5 years in supplemental funding through industry user fees to help the agency expedite access to generic drugs, enhance drug quality and safety, and ensure inspection parity of both foreign and domestic manufacturing sites.
“The Generic Drug User Fee Act is a milestone for the generic drug industry and a major win for American health care consumers,” said Ralph G. Neas, president and CEO of GPhA, in a statement
. “This program, as negotiated, will result in expedited access to low-cost, high-quality generic drugs for Americans and will further safeguard the quality and accessibility of our nation’s drug supply.”
The goals of the new program are available on the FDA’s generic drug user fee Web page
By the end of year 5 of the newly-established generic drug user fee program, the FDA will review and act on 90% of complete electronic ANDAs within 10 months after the date of submission (the current average approval time is 31 months). It will also review and act on 90% of all ANDAs and ANDA prior approval supplements regardless of current review status (whether electronic, paper, or hybrid) pending on October 1, 2012 by the end of FY 2017, which effectively eliminates the current application backlog.
GPhA has maintained that in the wake of increasing globalization in drug manufacturing—nearly 40% of all the prescription drugs Americans take are imported and up to 80% of the active pharmaceutical ingredients in those drugs come from foreign sources—the FDA needs more resources to ensure adequate oversight of the nation’s drug supply. Last year, the Government Accountability Office (GAO) reported that FDA was able to conduct Good Manufacturing Practice (GMP) inspections at only 11% of the foreign establishments in its database, compared to 40% of domestic sites. GDUFA can help significantly improve the FDA’s resources, ensuring that the work can be done with increasing speed but without any sacrifice to quality.
GDUFA also will provide the funding needed for FDA to achieve the same surveillance inspection frequency for both domestic and foreign manufacturers to insure that all industry participants in the US generic drug system are held to consistent GMP standards.
Given this development, GPhA believes the time has come to consider amending The Food, Drug and Cosmetic Act (FDCA) of 1938 to reflect the inspection model being established by GDUFA. The FDCA requires American drug manufacturers to undergo GMP surveillance inspections every two years, but it does not statutorily impose the same biennial inspection requirement on foreign facilities. This disparity should be remedied to create a level playing field for all manufacturers, foreign and domestic.
“Through GDUFA, the generic industry has truly stepped up to the plate to do our part to help insure US drug safety and establish a more level playing field among all participants in the US pharmaceutical supply chain,” said Neas. “In addition, this program will be of significant benefit to small businesses and first time entrants to the industry by helping to significantly reduce the time needed to commercialize a generic drug.”
GDUFA calls for the generic drug industry to pay $299 million annually for 5 years, which is supplemental to what Congress appropriates to FDA each year. GPhA said the new fees have been designed to spread fees across multiple stakeholders and sources to keep individual amounts as low as possible, and are not expected to add significantly to the cost of generic drugs.
The three key aims of GDUFA are:
Safety—Ensuring that industry participants, foreign or domestic, who participate in the U.S. generic drug system are held to consistent high-quality standards and are inspected by FDA biennially, using a risk-based approach.
Access—Expediting the availability of low-cost, high-quality generic drugs by bringing greater predictability to the review times for Abbreviated New Drug Applications (ANDAs) and by ensuring more timeliness in the drug review process.
Transparency—Enhancing FDA’s ability to protect Americans in the complex global supply environment by requiring the identification of facilities involved in the manufacture of generic drugs and associated APIs, and improving FDA’s communications and feedback with industry in order to expedite product access.