On December 13th the President signed into law the “21st Century Cures Act” (H.R. 34, PL 114-255 (the “Act”)). The legislation has been hailed as a variety of things including a tribute to Vice President Joe Biden; evidence of bipartisan cooperation in Congress; the most important health-related legislation since Obamacare; and a terrible piece of “pork barrel” legislation. (Legislation which favors specific interests in Congress.) What effect the election of Donald Trump and a Republican Congress may have on the Act is unclear, but certain provisions, no matter how they are influenced by subsequent events, are important to note.
- The Act does not contain an exemption which would have negated the requirement that drug and medical device makers report payments to physicians under a federal database established in 2014. The database tracks those types of financial relationships. That program, known and referred to as Open Payments, was part of the Affordable Care Act (“Obamacare”) and was established under the theory that fees for speaking engagements on products, free textbooks, and the like, might influence prescribing by the physicians involved with those activities.
- Much focus is on the U.S. Food and Drug Administration which is provided $500 million over ten years to implement speedier FDA approval of regulated health care items.
- The National Institutes of Health will receive $10 billion over 10 years for cancer and stem cell research.
- States will receive $1 billion for grants for opioid abuse treatment and prevention.
- Administrative burdens on researchers will be lessened.
- Efforts will be made to establish a global network devoted to pediatric study.
- Patient experience data will now be included in a statement attached to a drug’s approval by the FDA, such experiences to include not only those of patients but also those in a broad range of persons, organizations and institutions associated with patients.
- The FDA will be required to issue guidance on the manner in which patient experience is to be collected and submitted and how that data will be used.
- The FDA is permitted to bypass Paperwork Reduction Act requirements when seeking information from patients regarding their treatment so as to provide timely feedback from patients on the same.
- The FDA must report its review of patient experience data and information on patient=focused drug development tools according to a timeline in the Act.
- The Act establishes a review “pathway” for drug development tools to attempt to shorten drug development times and improve success in drug development.
- Regarding rare diseases, the Act clarifies the manner in which certain drug developers may rely on data for the same or similar technology from earlier approved applications by the same developer without altering standards.
- The FDA will have authority to waive or alter informed consent requirements for clinical trials with minimal risks associated with them.
- The Act allows the FDA to grant swifter approval for “regenerative therapeutic products”. Regulations and guidance regarding such products are to be updated by the FDA.
- Regulations are to be promulgated to allow the best manner in which the FDA may approve “combination products”, those allowing a medical device and biologic to be used together in treatment, and how disagreements within the FDA on the same are to be resolved.
- The FDA is granted more flexibility to approve certain drugs based on a “limited population” if the drug is designed to treat a life-threatening infection.
- Sponsors of devices will no longer be required to use a local institutional review board in seeking FDA approvals, instead employing the use of centralized models for review.
- Audits of FDA reviews are to be conducted by the FDA ombudsman in an attempt to ensure and track that the least burdensome means are being employed by the FDA in the drug and device approval process.
- The Act identifies five categories of medical software that will not be classified as “devices” if certain conditions are met.
The foregoing are just a few of the highlights of the Act’s 996 pages. For additional information on the Act or other legal matters contact one of PK Law’s Attorneys or firstname.lastname@example.org.
This information is provided for general information only. None of the information provided herein should be construed as providing legal advice or a separate attorney client relationship. Applicability of the legal principles discussed may differ substantially in individual situations. You should not act upon the information presented herein without consulting an attorney of your choice about your particular situation. While PK Law has taken reasonable efforts to insure the accuracy of this material, the accuracy cannot be guaranteed and PK Law makes no warranties or representations as to its accuracy.