Alexander readies companion bill to House-approved 21st Century Cures Act

U.S. Sen. Lamar Alexander (R-TN) shepherded the last of 19 bipartisan bills to committee approval on Wednesday to complete a companion legislative package to the House-approved 21st Century Cures Act.

Alexander, the chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, said that he was putting the finishing touches on a bipartisan legislative package that would help “virtually every American.”

“Because our Innovation — or ‘Cures’ — legislation will affect virtually every American, it will be the most important new law enacted this year,” Alexander said. “The legislation would create a breakthrough path for new medical devices like the breakthrough drug path approved in 2012 that has already attracted 384 applications and led to 39 approvals. It would give the FDA new authority to attract talented researchers, and reduce the administrative burden on (National Institutes of Health) and researchers. It would target rare diseases, including diseases resistant to antibiotics. It would allow NIH to require researchers who use NIH funds to share their data. It would encourage interoperability of electronic medical records, reduction in excessive physician paperwork, clarify each patient’s right to own their own medical record, and discourage information blocking.”

Groundwork for the Senate legislative package was laid throughout more than 100 hours of committee meetings, 10 hearings and three committee markups. The end result was 50 bipartisan proposals to help guide drugs, treatments and medical devices through the investment and regulatory process.

“The House has done its work,” Alexander said. “The president has proposed his initiatives. I am hopeful we can take this to the Senate floor soon and ensure the president’s Precision Medicine and cancer ‘moonshot’ initiatives and ideas in the ‘Cures’ bill can become reality this year.”

Leaders of the House Energy and Commerce Committee, Chairman Fred Upton (R-MI), Ranking Member Frank Pallone (D-NJ), Health Subcommittee Chairman Joseph Pitts (R-PA), Health Subcommittee Ranking Member Gene Green (D-TX) and U.S. Rep. Diana DeGette (D-CO) commended the bipartisan actions of the Senate HELP Committee.

“Time is short for millions of patients, and we are grateful to Chairman Alexander (R-TN) and Ranking Member Murray (D-WA) for their diligence and hard work in putting together a companion to 21st Century Cures,” Upton, Pallone, Pitts, Green and DeGette said in a joint statement. “The effort to deliver #CuresNow is not Republican or Democrat, but something we can only achieve together. We look forward to continuing our work and momentum with all stakeholders, including the White House, in order to make 21st Century Cures a reality for patients across the country.”

One of the key provisions of the legislative package include the Promise for Antibiotics and Therapeutics for Health Act, S. 185, sponsored by U.S. Sen. Orrin Hatch (R-UT) to hasten the development of treatments for “superbugs.”

U.S. Sens. Susan Collins (R-ME), Mark Kirk (R-IL) and Alexander cosponsored another bipartisan bill, the Advancing NIH Strategic Planning and Representation in Medical Research Act, S. 2745, to require the NIH to draft a strategic plan every six years.