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The senators' early warning provisions to give FDA the tools it needs to stop drug shortages before they occur passed the Senate last month as part of a larger Food and Drug Administration (FDA) bill, now must be included in final version of the legislation passed by the House and Senate before being signed into law

 

WASHINGTON, D.C. - U.S. Senators Amy Klobuchar (D-MN), Bob Casey (D-PA), Richard Blumenthal (D-CT) and Susan Collins (R-ME) called on congressional leaders to include their bipartisan provisions to help prevent drug shortages in the final Food and Drug Administration Safety and Innovation Act. The senators' provisions to require early warning notification and give the FDA the tools it needs to stop shortages of critical drugs passed the Senate last month as part of the larger FDA bill. In a bipartisan letter to the leaders of the Senate and House committees charged with oversight of the FDA, the senators urged their colleagues to include critical drug shortages provisions in the final version of the FDA legislation that must be passed by the House and Senate before being signed into law.

 

"Patients' energy should be focused on getting well - they shouldn't be burdened with the added stress and worry of whether or not they will have enough medicine to treat their condition tomorrow," Klobuchar said. "These common-sense reforms will help ensure that patients have access to the lifesaving drugs they need to stay healthy and prevent drug shortages from wreaking havoc on families' lives, and I will continue to work to ensure they are signed into law."

 

"The shortage of life-saving drugs has put the care of seriously ill patients in Pennsylvania and across America in jeopardy," Casey said. "I am calling on Senate and House leadership to recognize the urgency of this problem and ensure that the strongest version of this bipartisan legislation is included in the final FDA bill."

"No patient in the United States - a country that has developed the greatest lifesaving medicines - should ever have to worry about being deprived of the drugs they need," Senator Blumenthal said. "Our measure will help stop shortages in hundreds of workhorse medicines - Methotrexate, Mitomycin, Doxil, and Cytarabine - that are essential for prolonging and giving life to cancer patients who would otherwise die. We're also talking about Epinephrine - a drug that is important for allergy treatment. This life and death issue affects people in Connecticut and across the nation, and the reforms in the FDA bill must pass to ensure that we take an aggressive step forward on behalf of patients everywhere."

 

"I continue to hear from doctors, emergency medical personnel, and other medical professionals in Maine who are extremely concerned about this issue," said Senator Collins.  "Many of the drugs in short supply are vital, used in hospitals and cancer centers for anesthesia, chemotherapy, and treatment of infections.  There are also continuing shortages of drugs used in emergency rooms and intensive-care units.  These shortages are causing serious problems around the country, including forcing some medical centers to ration drugs or postpone elective surgeries.  It's critical that Congress address this crisis as quickly as possible."

 

The Food and Drug Administration Safety and Innovation Act includes a bipartisan drug shortages agreement that would require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage. This is the key provision in the Preserving Access to Life-Saving Medications Act, legislation Klobuchar and Casey introduced and Blumenthal and Collins cosponsored.  The FDA prevented nearly 200 drug shortages in 2011 due to voluntary early notifications from companies, up from 38 in 2010. During a recent FDA workshop, FDA officials said that the rise in preventions is due to increased pressure from Klobuchar and other members of Congress.

 

The agreement also includes two other provisions similar to the senators' legislation: it would direct the FDA to expedite inspections and reviews of manufacturing sites or new products that could be helpful in addressing a drug shortage, and require the FDA to keep detailed records of previous drug shortages and the actions taken to prevent them. It would also establish a task force to create a strategic plan to improve communication within the FDA and with public stakeholders, as well as commission a report on price gouging and how pricing structures factor into drug shortages.

 

In January, Klobuchar held a forum in Edina, Minnesota with Federal Trade Commission (FTC) Chairman Jon Leibowitz and Minnesota Attorney General Lori Swanson to discuss the drug shortages crisis and how to ensure patients have access to affordable medications. Klobuchar and Collins also recently took to the floor of the U.S. Senate to urge their colleagues to swiftly pass their legislation.

 

The full text of the letter is below.

 

June 14, 2012

 

The Honorable Tom Harkin

Chairman

Committee on Health, Education,

Labor, and Pensions

428 Dirksen Senate Office Building

Washington, D.C. 20510

 

The Honorable Michael B. Enzi

Ranking Member

Committee on Health, Education,

Labor, and Pensions

428 Dirksen Senate Office Building

Washington, D.C. 20510

 

The Honorable Fred Upton

Chairman

Committee on Energy and Commerce

2125 Rayburn House Office Building

Washington, D.C. 20515

 

The Honorable Henry A. Waxman

Ranking Member

Committee on Energy and Commerce

2322A Rayburn House Office Building

Washington, D.C. 20515

 

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.