Posted on March 9, 2016
WASHINGTON, D.C., March 9 – Following committee passage today of seven more biomedical innovation bills with bipartisan support, the Senate health committee chairman said the committee will finish its work at an April 6 meeting and ensure the promise of the president’s Precision Medicine and cancer moonshot initiatives and ideas in House’s 21st Century Cures can become reality this year.
“Today we marked up seven more bills incorporating about 15 more bipartisan proposals and that—with the seven bipartisan bills passed last month—gives a substantial start to our innovation companion to the 21st Century legislation passed by the House of Representatives,” said Sen. Lamar Alexander (R-Tenn.).“This committee produced an education bill that I considered to be the most important piece of legislation last year, and I think we can produce the most important bill of the Congress this year because our work on this bill will affect virtually every American.”
He added, “I want to finish our work promptly so we can hand to Sen. McConnell a conclusion on the innovation bill, as well as a bipartisan agreement on a surge of funding for the National Institutes of Health so he can put them on the floor.”
The following bills were passed by the committee today with bipartisan support:
· Sens. Casey (D-Pa.), Isakson (R-Ga.), Brown (D-Ohio), and Kirk (R-Ill.) – The Advancing Hope Act of 2015 (S. 1878): If you’re the parent of a child with a rare disease like brain cancer, this increases the likelihood that your child will be able to take a drug that will help him or her. This continues a program that gives drug companies a big incentive to develop a drug to treat or cure rare pediatric diseases—if a company develops a drug like that, and it’s approved, they get a voucher they can keep or sell that will speed up the review of another drug.
· Sens. Burr (R-N.C.), Bennet (D-Colo.), Hatch (R-Utah), and Donnelly (D-Ind.) –The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S.1077): This is a bill to help anyone whose health could be improved by a truly breakthrough device – it will focus more of Food and Drug Administration’s (FDA) attention and resources and put more senior people at FDA in charge of the review of these breakthrough devices so that they will move more efficiently through the review process and get to patients more quickly.
· Sens. Bennet (D-Colo.) and Hatch (R-Utah) – The Medical Electronic Data Technology Enhancement for Consumer’s Health (MEDTECH) Act (S. 1101): If you’re trying to lose weight and are hoping to use a helpful tool like the Weight Watchers application on your iPhone to count calories or a Fitbit watch to log the steps you take, this bill will encourage companies to develop these sorts of products free from unnecessary FDA oversight and red tape.
· Sens. Burr (R-N.C.), Casey (D-Pa.), Isakson (R-Ga.), and Roberts (R-Kan.) – The Medical Countermeasures Innovation Act of 2015 (S. 2055): This bill would ensure the government is planning ahead – if you are a victim in a bioterror attack with a substance such as anthrax or smallpox, this bill would increase the likelihood that there will be a drug to help save your life or help you get better. If a company develops such a drug and it’s approved, they get a voucher they can keep or sell that will speed up the review of another drug.
· Sens. Isakson (R-Ga.), Casey (D-Pa.), Donnelly (D-Ind.), and Roberts (R-Kan.) –The Combination Products Innovation Act of 2015 (S.1767): This bill will help the many Americans who will likely be helped by the growing field of combination products. Today we have bandaids with Neosporin built in, and heart stents that can be implanted to also deliver blood thinners to prevent clots – and many more combination products are coming – and this bill will help prevent them from being caught in regulatory red tape between various departments at FDA.
· Sens. Wicker (R-Miss.), Bennet (D-Colo.), Collins (R-Maine), and Franken (D-Minn.) – Patient Focused Impact Assessment Act of 2015 (S. 1597): If you are the parent of a child who can hardly see because of a rare genetic disorder, and your child enters a clinical trial for a drug that allows her to regain even half her sight, but it gives her a rash that doesn’t bother her too much – you’d probably want FDA to know that you and your child think the rash is worth it. It’s worth the ability to see better, and you don’t want it to hamper the drug’s approval. This bill would give patients and their families a voice in the approval process, and would require FDA to hear your opinion.
· Sens. Franken (D-Minn.), Nelson (D-Fla.), Isakson (R-Ga.), and Brown (D-Ohio) – Adding Zika to the Priority Review Voucher Program Act (S. 2512) – This means a faster treatment, cure or vaccine for the Zika virus that appears to be the cause of heartbreaking birth defects. It gives drug companies a big incentive to develop a drug or vaccine for Zika—if a company develops a drug like that, and it’s approved, they get a voucher they can keep or sell that will speed up the review of another drug.
Click HERE for Chairman Alexander’s full opening remarks today.
Click HERE for a list of legislation that passed the committee’s February #Innovation2016 meeting with bipartisan support.