On May 30, 2012, the U.S. House of Representatives approved legislation to renew the user authorization fees drug and device companies must pay to the Food and Drug Administration ("FDA") by a 387-5 vote.  The bill will reauthorize user fees from prescription drugs and medical devices, and it will create new user fee programs for generic drugs and biosimilar drugs.  The House passage of the bill follows the Senate's approval of its version of the bill on May 24, 2012.  Now, the differences between both bills will be settled by a conference committee comprised of certain Senate and House members. The current user fee bills are set to expire on September 30, 2012.

The House version of the user fee bill would authorize the FDA to collect billions of dollars from 2013 through 2017 from manufacturers for FDA to hire more individuals to expedite the review process of new drugs and devices.  Nearly 30 percent of the fees would come from new fees paid by generic drug makers.  These funds will allow the FDA to hire approximately 800 new staffers in an effort to eliminate the backlog of 2,700 generic drug applications and decrease the typical review time for a generic drug from over 30 months to approximately 10 months.  The bill will also speed up the review times for new, one of a kind drugs used to treat life-threatening diseases by accepting shorter and smaller clinical studies in its review process.  Last, the bill would require the FDA to provide medical device manufacturers with a reason for denying the approval of medical implants within 30 days from the date of the denial.  These measures aim to address current product approval issues and increase review times for necessary drugs and devices.

The bill also includes provisions that will address concerns regarding the safety of prescription drugs.  First, the bill would provide the FDA more flexibility to focus its inspections on foreign facilities where drugs are increasingly produced.  Previously, the FDA had focused its inspections on facilities in the United States. Recently, however, many companies have moved their operations overseas.  As a result, approximately 80 percent of the ingredients used in drugs found in the United States are made abroad.  The bill would eliminate the requirement that the FDA inspect U.S. facilities every two years and enable inspectors the freedom to inspect any facility the FDA believes to have manufacturing problems, regardless of location.  This change in focus means that foreign facilities, which the FDA had inspected on average approximately once every nine years, would likely face more frequent agency inspection.  In addition, the bill would increase the penalty for counterfeiting of drugs from three years in prison to up to 20 years in an effort to combat increasing reports of drug counterfeiting.

To review the text of the House bill, please click here.  Megan Fanale Engel