Before the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) presents a legislative package of healthcare reforms to the Senate floor for an up-or-down vote, 13 consumer, patient and health non-profit groups sent a letter to HELP Chairman and Ranking Member to ensure that the final legislative package includes only those bills that the HELP Committee reviewed in mark-up sessions.
The letter was addressed to Chairman Lamar Alexander, R-Texas, and Ranking Member Patty Murray, D-Wash., and explained concerns about measures approved in the House of Representative’s 21st Century Cures Act and their lack of review by the Senate.
The letter asked the Committee leaders to ensure that the Senate observes “regular order” in passing their package of bills:
“Any maneuver resulting in a final legislative package that includes some or all of the dangerous provisions in the House 21st Century Cures Act that were not discussed during the Senate mark-up would constitute an unacceptable end-run around a normal legislative process, exactly the kind of cynical maneuvering feeding public distrust with the workings of the U.S. Congress.”
KEI is one of the co-signatories on the letter, and is particularly concerned about provisions that would lengthen periods of marketing exclusivity for pharmaceutical products, such as the Orphan Products Extensions Now Accelerating Cures and Treatments (OPEN ACT) Act (S.1421, section 2151 of H.R.6), or otherwise limit access to pharmaceuticals.
We’re worried that backdoor mechanisms will allow some of the worst components of the House-passed 21st Century Cures initiative to make it into a conference-passed bill. We wrote this letter to ensure that those provisions aren’t packaged with things that are much milder and passed with the veneer of bipartisanship.
Lisa Gilbert, Director of Public Citizen’s Congress Watch, said:
“We’re worried that backdoor mechanisms will allow some of the worst components of the House-passed 21st Century Cures initiative to make it into A final bill. We wrote this letter to ensure that dangerous provisions aren’t packaged with things that are much milder, and then passed with the veneer of bipartisanship.”
The full letter is reproduced below and available as a PDF.
Dear Chairman Lamar Alexander and Ranking Member Patty Murray of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee:
We, the undersigned organizations represent healthcare providers, clinical researchers, public health experts, and consumer advocates across the country. Over the last three months your committee has marked-up and passed bills with a goal of creating a package of Senate health reforms that could ultimately become an unofficial counterpart to the 21st Century Cures Act passed by the U.S. House of Representatives.
We write to urge that members invested in patient safety, access to affordable medicines, and biomedical innovation observe “regular order” as these Senate bills are combined into one package, introduced, and voted on before the full Senate, and potentially conferenced with the much more far-reaching House 21st Century Cures Act.
Any maneuver resulting in a final legislative package that includes some or all of the dangerous provisions in the House 21st Century Cures Act that were not discussed during the Senate mark-up would constitute an unacceptable end-run around a normal legislative process, exactly the kind of cynical maneuvering feeding public distrust with the workings of the U.S. Congress.
We are concerned that as the Senate counterpart moves through the legislative process, floor amendments and conference committee negotiations could include proposals that endanger the lives of patients and curb access to affordable treatments. This includes proposals that would dangerously require the FDA to recklessly speed the review of certain “breakthrough” medical devices by restricting the FDA’s ability to request new evidence during clinical development, and lower drug approval standards by pressuring the FDA to rely more heavily on “evidence from clinical experience,” meaning sources other than randomized, controlled clinical trials, the gold standard for medical research.
An additional example of the many proposals we fear is section 2151 of the 21st Century Cures Act. This section would bar generic entry of certain medicines into the market for a longer period, denying patients access to affordable life-saving medicines.
These and other dangerous proposals should be omitted from any final legislation. The threat of their inclusion is real, as worrying provisions from the 21st Century Cures Act are already making their way through Congress as proposed attachments to “must-pass” appropriations legislation. Proposals that were inserted as policy riders in the House appropriations process were lifted from Title II of the 21st Century Cures Act. Title II dealt with drug and medical device approval standards and development. Your committee and the Senate as a whole must ensure that these proposals are kept far away from any FDA reform package.
The sweeping 21st Century Cures Act that passed the U.S. House of Representatives contains many provisions that put lives at risk. They have no place in your bill as your package is voted on before the full Senate and enters conference.
The Annie Appleseed Project
Breast Cancer Action
Center for Medical Consumers
Knowledge Ecology International
National Physicians Alliance
Treatment Action Group
Universities Allied for Essential Medicines
The Veterans Health Council
Vietnam Veterans of America
Young Professionals Chronic Disease Network