Letter to the Honorable Tom Harkin, Chairman on the Committee on Health, Education, Labor, and Pensions, the Honorable Michael B. Enzi, Ranking Member Committee on Health, Education, Labor, and Pensions, the Honorable Fred Upton, Chairman on the Committee on Energy and Commerce, and the Honorable Henry A. Waxman Ranking Member Committee on Energy and Commerce

Letter

The Honorable Tom Harkin
Chairman
Committee on Health, Education, Labor, and Pensions

The Honorable Michael B. Enzi
Ranking Member
Committee on Health, Education, Labor, and Pensions

The Honorable Fred Upton
Chairman
Committee on Energy and Commerce

The Honorable Henry A. Waxman
Ranking Member
Committee on Energy and Commerce

Dear Chairman Harkin, Ranking Member Enzi, Chairman Upton and Ranking Member Waxman:

We want to thank you for your leadership in crafting Food and Drug Administration (FDA) user fee reauthorization bills that passed with strong bipartisan support in the Senate and the House. This legislation will ensure patient safety, access to the newest cures and therapies, and job growth in America, and will make a huge difference for patients in Pennsylvania, Minnesota, Connecticut, Maine, and across the Nation.

As authors and sponsors of the original Senate version of the drug shortage legislation, the Preserving Access to Life-Saving Medications Act (S. 296), we appreciate the inclusion of the early notification provision in the final Senate bill. However, as you work to merge the House and Senate versions of the FDA user fee reauthorization bills, we ask that you take into consideration certain policies we feel would improve the FDA's ability to address drug shortages and ensure patients have continued access to the life-saving medications that they need and deserve.

While both versions include language setting out early notification requirements, we believe it is vital to make clear that manufacturers of all drugs, including biologics, immediately and explicitly be included within the requirement. This is a matter of public health, and we must ensure that no patient -- regardless of the type of medication they take -- falls through the cracks because of a lack of immediate protection under the law. It has always been the intent of Congress to include these products under the early notification requirement and we hope the final bill language will reflect those goals. As an example of how important it is to include biologics without delay, we would point you to the bladder cancer drug, Bacille Calmette-Guerin, or BCG, which is currently listed on FDA's shortage list. There is no approved alternative therapy to BCG, so this drug shortage poses a serious threat to the effective treatment of tens of thousands of bladder cancer patients, as described in the attached article from the Pittsburgh Post-Gazette.

Additionally, both versions include efforts the FDA can take to address noncompliance among manufacturers with the early notification requirement. The Senate bill directs the FDA to produce an annual report that lists manufacturers who fail to comply with the early notification requirement, while the House approach would trigger an automatic letter from the FDA requesting an explanation from the manufacturer. While both approaches would place additional public scrutiny on the offending manufacturer, we feel that the approach taken in the House would do so on an accelerated timeline. We would prefer that both approaches be preserved in negotiations.

We also support provisions that would increase communication both inside and outside the FDA. To that point, we support including language that would further collaboration between the FDA and the Drug Enforcement Agency and allow for more flexibility when addressing quotas for controlled substances. We also support including language from the Senate bill that would establish a task force to consult with external stakeholders to develop a strategic plan for preventing and mitigating drug shortages. We believe that improved communication with all stakeholders will increase FDA's ability to work in partnership to more proactively prevent and manage shortages by identifying past problems, improving cooperation, and reducing regulatory hurdles, and helping patients get access to the essential medications. Finally, we support language in the Senate bill to assess the impact on federal health programs of potential price-gouging practices as a result of the drug shortage crisis.

Again, we thank you for your leadership in helping us move forward legislation to prevent and alleviate the drug shortage crisis. I hope we can continue to work together to finalize and pass this critical legislation.