Congress Agrees on User Fees & Targeted Inspections For FDA |

With presidential politics in full swing it’s hard to find an issue in Washington where bipartisan support exists. But in the past two weeks both legislative chambers have overwhelmingly supported user fees and targeted inspections for the federal agency responsible for the food Americans eat and the drugs we take every day.

Overwhelming

Last week the U.S. House of Representatives adopted H.R. 5651, the Food and Drug Administration (FDA) Reform Act of 2012, under “suspension of the rules” which is used to pass non-controversial bills. In the previous week, the U.S. Senate adopted their version by a vote of 96-1.

Some of the provisions of the legislation include:

Approves $6.4 billion in user fees over five years, just over $600 million will be generated from medical device user fees that companies will pay to the FDA;
User fees will be used to expedite medical device reviews and make drugs available to patients sooner;
Expedites the approval process of certain prescription drugs;
Alleviates the national prescription drug shortage by adjusting requirements; and
Provides transparency allowing the public a list of prescription drugs in short supply.

80% of U.S. Medicine Ingredients are from Overseas

In addition to the user fees, the legislation makes sweeping reforms to the FDA’s inspections. For the past 70 years FDA has focused its inspections on U.S. drugmakers (inspections every two years). But the reality is 80 percent of ingredients used in medicines provided to patients in the U.S. are made overseas including countries such as China and India. FDA inspects the average foreign manufacturing facility just once every nine years. The legislation would now focus FDA inspectors to target the most problematic manufacturing sites, regardless of location.

In a recent statement, FDA Commissioner Dr. Margaret Hamburg called the bill’s passage “innovative” and said it will improve “access to safe and effective medical products.” Actual results are yet to be determined.

User Fees As A Revenue Generator for Government

What is profound about this is that amidst partisan bickering, common ground was found overwhelmingly on the issues of user fees and targeting inspections to manufacturers with a history of violations. With austere budgets ahead at the local, state and national levels for the foreseeable future Congress is agreeing to user fees as a revenue generator and implementing methods that achieve efficiencies in government program delivery. This rare bipartisan tone in Washington may be enough to hasten state and local governments to move in the same direction of user fees and targeted inspections.

Federal lawmakers from both legislative chambers will work out their differences in a conference committee, likely in July. It is estimated the legislation will become law prior to the new fiscal year beginning October 1.

Cansler Consulting is an experienced lobbying firm in Food and Drug safety, budgeting, agriculture, rural healthcare, and energy policies and through our Congressional relationships we can help you influence the policy makers on Capitol Hill. You can contact us at [email protected] or at (202) 220-3150.

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Tim Cansler

Chief Strategist at Cansler Consulting, LLC

Tim has over 30 years of extensive experience in federal legislative and regulatory matters. His trusted advise helps clients navigate federal government processes to successful policy outcomes. He is a member of the National Institute for Lobbying and Ethics in Washington, D.C.