In a rare display of bipartisanship, the House passed a measure yesterday that would reauthorize Food and Drug Administration user fees for five years and establish new user fees for the FDA’s review of generic drugs and biosimilar products.
The fees go towards the facilitation of the FDA’s review and approval process of life-saving and life-improving drugs and medical devices. The user fees that have been reauthorized will not only make the FDA’s review and approval process of drugs as efficient as possible, it will also make the process more transparent and more certain.
In exchange for an increase in fees paid by the drug companies, the FDA has agreed to meet more frequently with drugmakers throughout the review process in the hopes of producing faster, safe drug approvals. The FDA will also implement specific performance goals and reforms to ensure patients receive quality care and access to new therapies.
This agreement will improve the lives of American patients and support American innovation. It will keep and create global medical device and biopharmaceutical jobs here in the U.S., and enable the U.S. to continue to be the world leader in these industries.
The user fee program has been a great success over the last two decades, as the increased funding from pharmaceutical companies has enabled the FDA to add about 200 staff members and lessen the drug review process almost in half. A 2002 Government Accountability Office report found that the average approval time dropped from 27 months to 14 months over the first eight years of the act, and user fees increased new drug reviewers by 77 percent.
The measure passed yesterday takes substantial steps to making certain that Americans get improved access to safe, innovative medicines and medical devices while decreasing prescription drug costs and modernizing the FDA. The user fee legislation will bring FDA critical dollars to expedite its review of drugs and medical devices, and now generic drugs and biosimilars. Consequently, patients will have access to advanced and innovative therapies in a timely manner.
The process of which this measure was drafted, negotiated and agreed upon should be a model for Congressional bipartisan cooperation. The measure reflects a great deal of input from key stakeholders such as patient advocates, medical providers, health care professionals, and academia. It shows that indeed Congress can still function when it comes to critical issues like this one.
Now the Senate must act quickly to approve one of 2012’s must-pass legislations so that the FDA can be provided with the much-needed resources to promote innovation through greater transparency, predictability, and efficacy in its drug review program. This, in turn, will strengthen America’s health care system, foster greater innovation, stimulate the economy and create American jobs.
Douglas E. Schoen is a political strategist, Fox News contributor, and author of several books including the recently released, “Hopelessly Divided: The New Crisis in American Politics and What It Means for 2012 and Beyond” (Rowman and Littlefield).
I invite you to follow me on Twitter @DouglasESchoen