Regulatory Approval for 21st Century Medicine
House Passes Legislation To Streamline FDA Approvals
On July 10, 2015, the House of Representatives, by a vote of 344-77, passed a bill designed to speed the process by which medical treatments are made available to patients. Dubbed the 21st Century Cures Act, this 364-page bill is sponsored by Reps. Fred Upton (R-MI) and Diana Degette (D-IL). The bill would significantly increase NIH funding by $8.75 billion and FDA funding by $550 million.
The bill would streamline the lengthy process used by the Food and Drug Administration (FDA) to approve new drug treatments:
- For certain supplemental drug applications, the bill would allow a product developer to submit a data summary versus a full data set.
- For serious or life-threatening bacterial or fungal infections for which there is a lack of treatment alternatives, the bill would allow FDA to approve new antibiotics though a streamlined approval process that will vary, depending on the circumstances.
- For vaccines, the bill requires expedited action by the Advisory Committee on Immunization Practice regarding recommended uses of a newly licensed vaccine.
- For an existing drug approved for a new indication to treat a rare disease or condition, FDA will extend its “exclusivity” by six months.
The bill would also streamline the review process for medical devices:
- The bill would establish a new program for certain “breakthrough technologies”: (1) those for which no approved alternatives exist, (2) offers significant advantages over existing approved or cleared alternatives, and (3) the availability of which is in the best interest of patients. Specifics on the review process are to be determined through guidance developed by FDA.
- The bill would create a third-party certification program for device-related changes that would avoid full FDA review and submission of certain paperwork requirements.
- The bill would allow FDA to recognize certain consensus standards and thereby eliminate the need for certain requirements.
- The bill would allow FDA to exempt any Class I and Class II device manufacturer from submitting certain required reports.
The Senate is developing a companion bill that has yet to be introduced. Given broad bipartisan support, he legislation stands a good chance of enactment in this Congress.
Public Comments on Regulatory Coverage of Medical Apps
Last week, FDA released public comments on its revised guidance on mobile apps that may be medical devices subject to regulatory approval. Although the public comments were generally favorable toward the guidance, several commenters requested greater clarity and some requested regulatory changes consistent with the guidance.
In recent years, technology firms have introduced a long line of smart phone apps designed to advance a healthier lifestyle. And consumers are buying them. At the same time, health information technology has advanced significantly, including the linking of mobile apps to medical devices for patient monitoring. But where do you draw the line between an app that provides information and an app that acts as a medical device, which requires regulatory approval?
On February 9, 2015, FDA issued revised guidance describing where it wants to draw the line. Most mobile apps are not medical devices under the Federal Food, Drug, and Cosmetic Act (FFDCA), and some may be medical devices, but pose low risk to patients. FDA plans to exercise enforcement discretion for the latter situation, and will focus its attention on medical devices that could pose a significant risk to patients.
The guidance document provides specific examples of mobile apps that are not medical devices, that may be medical devices but pose low risk (and therefore won’t be enforced), and that are medical devices and could pose significant risks (and therefore will be enforced). FDA is expected to modify its guidance in response to the public comments.