In mid-July, the House of Representatives passed HR 6, also known as the 21st Century Cures Act, which expedites research and development on debilitating diseases and makes it easier to get important treatments to the patients who need them. Among other things, it makes research collaborations easier, reforms and streamlines clinical trials, creates an Innovation Fund to encourage young scientists to do path-breaking research, and puts more money into both the National Institutes of Health and the FDA to make these innovations work.
Regarding medical devices, this bill would redefine the evidence on which high-risk devices can be approved to include case studies, registries, and articles in the medical literature, rather than more rigorous clinical trials. It also makes changes to the humanitarian device exemption. In addition, the Act also extends funding for the National Institutes of Health for the next five years.
Rep. Fred Upton (R-Mich.), chairman of the House Committee on Energy and Commerce, who introduced the bill, said: “The United States has led the global medical device and biopharmaceutical industries for decades, helping us become the medical innovation capital of the world and causing China and others to try to take our innovation and jobs…The policies in HR 6 will help us fight off foreign competitors so we can keep these jobs, and add more, here at home.”
Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), had this to say: “AdvaMed commends the passage of the 21st Century Cures Act. The bill includes a number of proposals designed to strengthen the innovation ecosystem and support the development of life-saving, life-enhancing medical technology. This includes key improvements to FDA’s premarket program for medical devices—most significantly the establishment of an expedited pathway for breakthrough, innovative technologies—which will increase the efficiency, predictability, and transparency of the agency’s review process and improve patient access to the best in medical progress.
Perhaps by the time you read this, the Senate may have voted as well.
Also in July, the FDA issued a guidance document “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements,” which, as the title implies, describes the agency’s intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices from premarket notification requirements. This move essentially exempts 120 medical device classes from its premarket notification and review requirements, which will make it much easier for companies to get the devices to market. The FDA believes the devices identified in the guidance are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness. These devices include anesthesiology devices, some cardiovascular devices, monitors, and more.
The FDA recently celebrated the third anniversary of the FDA Safety and Innovation Act (FDASIA). FDASIA gave the FDA the authority to collect user fees from industry over 5 years, beginning in 2012, to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biological products. It also increases stakeholder involvement in FDA processes, promotes innovations that will speed patient access to safe and effective products, enhances safety of the drug supply chain, and helps prevent drug shortages.
In a blog post on the FDA site, Stephen M. Ostroff, MD, writes: “In 2014, in response to Congress’s request in Section 907 of FDASIA, we produced an Action Plan to help close gaps in data quality, clinical trial participation, and data access. We have issued a guidance document on the ‘Evaluation of Sex-Specific Data in Medical Device Clinical Studies,’ and we’re working to promote clinical trial participation by women and minorities.”
It sounds like the FDA is moving ahead on a number of innovations that will help streamline the development of life-saving devices and drugs. Let’s give credit where credit is due.
