The U.S. has always been a leader in medical innovation, and yet without a renewed effort to ensure our policy framework supporting it is up-to-date, we risk not just falling behind other nations, but depriving our patients of much-needed cures.
It’s no secret that this very unconventional presidential race has caused our country to suffer from a serious case of partisanship and political upheaval. I’ll refrain from commenting on any of the particular candidates or their positions, but as a physician, I will do my best to recommend a course of treatment. If we’re looking to build a bridge between parties and ideologies, there is no better answer than to start with what already makes our country a success: our collective ingenuity and creativity to innovate, and specifically in the medical field.
Considerable bipartisan effort has already been made over the last two years to develop legislative proposals aimed at bolstering U.S. medical innovation and speeding access to new drugs and medical devices. The House Energy and Commerce Committee’s efforts have given us H.R. 6, the 21st Century Cures Act, which passed the House last year 344-77, and the Senate Health, Education, Labor, and Pensions Committee has produced a slate of 19 bipartisan bills targeting many different aspects of the innovation issue.
While the differences in the two approaches still need to be ironed out, several of the provisions contained in each hold promise in areas such as modernizing clinical trials, improving the approval process, integrating patient perspectives in the development process, fostering precision medicine, improving EHR interoperability, and ensuring the FDA and NIH can attract the workforce they need to be successful, among other things.
Are these proposals absolutely perfect? No, like any product of compromise, there are things that could be different. As a specialist, I’d like to see provisions to adequately remove limits to physicians’ ability to share off-label information, to lessen physician burden under the EHR/Meaningful Use program, and to implement an appeals process for when certain drugs or devices are not approved. The current legislative proposals are a good start and the Senate should pass the legislation. We owe it to our patients to move ahead now.
There are fewer and fewer days left in the Congressional calendar. While the key outstanding issue is how to provide substantial funding for the National Institutes of Health (NIH), the legislation as a whole remains popular on both sides of the aisle.
On behalf of my colleagues in the specialty physician community, and most importantly our patients who are waiting to take advantage of the new technology and cures we as American innovators are so adept at producing, I ask legislators to come together and complete work on the package before time runs out this Congress. Failure to act on innovation legislation now doesn’t just reset the clock in January; it could prevent someone from receiving a cure they need.