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By Jeannie Baumann
Jan. 20 — Parts of a multi-bill legislative package on biomedical innovation are scheduled to undergo Senate markup in early February, marking a critical step toward moving forward companion legislation to the 21st Century Cures bill (H.R. 6) that the House passed in July.
The Senate Health, Labor, Education and Pensions (HELP) Committee announced that it has scheduled an executive session for Feb. 9, when lawmakers are expected to vote on bills on topics that range from electronic medical records to rare diseases.
As the first of three executive sessions on biomedical innovation, the announcement by HELP Chairman Lamar Alexander (R-Tenn.) indicates a change of strategy from the House. Under the new plan, which was first reported by Morning Consult, the HELP committee would move more incrementally by considering three rounds of individual bills rather than voting on a single piece of legislation.
Alexander and Sen. Patty Murray (D-Wash.), the top Democrat on HELP, began their bipartisan medical innovation initiative about a year ago, and Alexander initially said he wanted to have full committee approval of a bill by the end of 2015. In the announcement issued late Jan. 19, Alexander said senators and staff have been working together throughout 2015 to produce a number of bipartisan bills that are ready for the full committee to consider.
“It is urgent that the Senate finish its work and turn into law these ideas that will help virtually every American,” Alexander said both in his statement and while presiding over a Jan. 20 HELP hearing on mental health.
• bipartisan legislation to improve electronic health records, which the HELP committee released in draft form Jan. 20;
• the FDA Device Accountability Act of 2015 (S. 1622);
• the Advancing Targeted Therapies for Rare Diseases Act of 2015 (S. 2030);
• the Advancing Research for Neurological Diseases Act of 2015 (S. 849);
• the Next Generation Researchers Act (S. 2014);
• legislation on Food and Drug Administration regulation of duodenoscopes, which are flexible, lighted tubes used to examine the digestive tract that have been linked to spreading deadly superbugs .
The second HELP executive session, scheduled for March 9, will consider bipartisan legislation to modernize the National Institutes of Health and the FDA and provide support for the White House's Precision Medicine Initiative to transform the practice of medicine by providing more targeted treatments to patients.
One issue widely considered to be a critical hang up in moving the Senate bill was whether it would include mandatory funding increases for the NIH and the FDA as did the House version (9 LSLR 1169, 10/16/15).
“The Senate was pretty clear from the get-go that they don't have same jurisdiction to create pay-fors that [the Energy and Commerce Committee] did on the House side,” Margaret Anderson, executive director of the medical progress think tank FasterCures, told Bloomberg BNA Jan. 20.
Congress included a $2 billion increase for the NIH in the last budget cycle, which Anderson said indicated a strong recognition of the power of investing in the NIH. “I still think there’s a great possibility for [the Senate] to tackle some work around mandatory NIH and FDA funding and to amplify that dialogue, which is critically important,” she said.
• Advancing Hope Act of 2015 (S. 1878),
• Medical Countermeasures Innovation Act of 2015 (S. 2055),
• Combination Products Innovation Act of 2015 (S.1767),
• Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077) and
• legislation on precision medicine and to “ensure that the NIH has the tools it needs to research treatments that are individualized for patients.”
Alexander didn't list any bills for the final session scheduled for April 6 but said the session would complete the HELP committee's action for its biomedical innovation initiative.
Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.), the authors of the House 21st Century Cures measure, praised Alexander's announcement in a joint statement issued late Jan. 19.
“The Senate announcement is just the latest positive milestone in the effort to give patients and their loved ones more hope. But we have much work left to do to make 21st Century Cures a reality. The vice president is working on a ‘moon shot’ to cure cancer, and we’ve got a rocket ship ready to go,” the joint statement said.
Anderson of FasterCures called Alexander's announcement a “hugely important” next step and said she wasn't concerned that the Senate package is no longer a single bill. “I really think Chairman Upton, congresswoman DeGette and the folks on the House side are very eager to get to conference by the looks of it,” she said.
Since the biomedical initiative started, there have been a number of advancements in the biomedical research landscape, from the so-called moonshot cancer initiative to the HELP committee's approval of FDA commissioner nominee Robert Califf (10 LSLR 02, 1/22/16).
Anderson told Bloomberg BNA that she's interested to see how the Senate approaches all these issues once lawmakers release more details of their plan.
“The world’s evolving really quickly in this space,” Anderson said.
Mary Woolley, president of Research!America, called the Senate action terrific news. “Researchers, advocates and patients alike have been anticipating policies and funding to support the NIH and FDA in ways that will advance medical progress,” she told Bloomberg BNA in a Jan. 20 statement.
JC Scott, senior executive vice president of government affairs for the medical device trade group Advanced Medical Technology Association (AdvaMed), also praised the HELP announcement. He said the mark-up schedule includes several pieces of legislation that would improve the efficiency of the FDA's medical technology review process and eliminate redundant regulatory obstacles, such as expediting FDA approval of breakthrough medical technologies, improving the agency's review process for combination products and improving the process for waiving requirements under the Clinical Laboratory Improvement Amendments.
“The medical technology industry strongly supports the HELP Committee's efforts to take a comprehensive approach to speeding the development and delivery of new medical advancements in the U.S.,” Scott said.
To contact the reporter on this story: Jeannie Baumann in Washington at email@example.com
To contact the editor responsible for this story: Randy Kubetin at firstname.lastname@example.org
More information on HELP committee hearings and executive sessions is available at http://www.help.senate.gov/hearings?mode=calendar
More information on 21st Century Cures is available at http://energycommerce.house.gov/cures.
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