The Food and Drug Administration (FDA) recently released new draft guidance documents to clarify its approach to regulating software as a medical device. The first draft guidance, Clinical and Patient Decision Support Software, addresses provision of the 21st Century Cures Act that exempts certain clinical decision support software from the definition of a medical device. The … Continue Reading
On June 8, 2017, the Energy and Commerce Committee voted unanimously to approve an amended version of HR 2430, the FDA Reauthorization Act (FDARA) of 2017. The bill would extend the FDA prescription drug, medical device, generic drug, and biosimilar biological product user fee programs, which are scheduled to expire at the end of September. … Continue Reading
President Trump has released his FY 2018 budget proposal, which the Administration dubs “A New Foundation for American Greatness.” The proposed budget – which received a generally chilly reception on Capitol Hill – offers a mixed bag for the health care industry. On the one hand, a document summarizing the Department of Health and Human … Continue Reading
The Senate voted May 9, 2017 to approve the nomination of Scott Gottlieb, MD, to serve as Commissioner of Food and Drugs, by a vote of a 57-42. Dr. Gottlieb was sworn in on May 11.… Continue Reading
As previously reported, President Obama has signed into law the 21st Century Cures Act (PL 114-255), which is intended to spur the discovery and availability of new medical treatments. Reed Smith has prepared a client alert summarizing the major drug, device, and biologic development and approval provisions contained in the Cures Act. The alert is … Continue Reading
The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have announced that they are making permanent their “Program for Parallel Review of Medical Devices,” which is now operating as a pilot program. The parallel review initiative allows concurrent FDA and CMS review of a medical device with the goal … Continue Reading
As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The meeting comes at a time where recent litigation has raised hot-button issues regarding the relationship between FDA, off-label use of drugs … Continue Reading
On September 30, 2016, President Obama signed into law S 1878, the Advancing Hope Act, which modifies the FDA’s priority review voucher program for rare pediatric diseases and extends the program through December 31, 2016. In addition, the House has approved a number of health policy bills, including the following: HR 954, the “CO-OP Consumer … Continue Reading
On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to inform FDA’s “comprehensive review of its regulations and policies” pertaining to such communications. The FDA poses a number of specific questions … Continue Reading
The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the last of its biomedical innovation bills that form its counterpart to the House 21st Century Cures Act. Together with the bills cleared by the HELP committee in February and March 2016, the panel has now passed 19 bipartisan medical innovation bills. The five … Continue Reading
On April 12, 2016, the House of Representatives gave final approval to S. 2512, which would add the Zika virus to the FDA Priority Review Voucher Program that encourages treatments for tropical diseases. The bill, which was passed by the full Senate on March 18, 2016, is now cleared for the President’s signature.… Continue Reading
The Senate Health, Education, Labor and Pensions (HELP) Committee approved seven bills this month that are intended to promote biomedical innovation, building on legislation approved by the panel in February. Specifically, on March 9, the Committee approved: S. 1878, the Advancing Hope Act of 2015 — to extend and expand an FDA priority review voucher … Continue Reading
The Senate Health, Education, Labor and Pensions (HELP) Committee has approved several bipartisan health policy bills, including health information technology (HIT) legislation and bills aimed at spurring biomedical innovation to complement the “House 21st Century Cures” initiative. Specifically, on February 9, 2016, the Committee approved:… Continue Reading
On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance details the agency’s specific recommendations, which address monitoring, identifying and managing cybersecurity vulnerabilities in medical devices that are software, or contain software (including firmware) or programmable … Continue Reading
The Senate Health, Education, Labor and Pensions (HELP) Committee has announced its plans to consider companion legislation to the House-approved “21st Century Cures Act,” which is intended to improve the drug and device development processes and expedite patient access to medical treatments. The Senate currently plans three sessions to consider components of its biomedical innovation … Continue Reading
On March 2, 2016, the FDA is hosting a public workshop on “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.” FDA is convening the workshop to discuss the specific information patients and providers prefer to receive, how those results should be returned, and the information needed to understand such results so … Continue Reading
President Obama has signed into law H.R. 1321, the “Microbead-Free Waters Act of 2015.” The new law prohibits the manufacture, sale, or distribution of rinse-off cosmetics (including toothpaste) containing intentionally-added plastic microbeads to prevent the microbeads from getting into waterways. The act also preempts state law with respect to the manufacture or introduction or delivery … Continue Reading
As discussed on our sister Life Sciences Legal Update blog, the FDA is holding a public two-day workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” on January 20-21, 2016. The FDA seeks to bring together diverse stakeholders to highlight past collaborative efforts, identify tools to aid stakeholders in implementing disclosure and vulnerability management, … Continue Reading
On November 16, 2015, the House of Representatives approved HR 639, the Improving Regulatory Transparency for New Medical Therapies Act, clearing it for the President. The legislation would amend the Controlled Substances Act (CSA) to make procedural changes intended to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency’s (DEA) process for scheduling … Continue Reading
Several Congressional hearings are scheduled next week and into December on health policy issues, including: A November 17 Senate Finance Committee hearing entitled “Physician Owned Distributors: Are They Harmful to Patients and Payers?” A November 17 House Judiciary Subcommittee on Regulatory Reform hearing on “The State of Competition in the Pharmacy Benefit Manager and Pharmacy … Continue Reading
On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the Common Rule (45 C.F.R. Part 46). Under the current regulations, the Common Rule applies to all research involving human subjects that is conducted … Continue Reading
On August 28, 2015 the federal Food and Drug Administration (“FDA”) issued two important policies regarding naming biological products, including biosimilars. First, FDA released a notice announcing the availability of draft guidance entitled “Nonproprietary Naming of Biological Products.” The draft guidance highlights FDA’s current thinking on the need for biological products licensed under the Public … Continue Reading
Earlier this week, the federal Food and Drug Administration (FDA) issued a notice in the Federal Register (80 Fed. Reg. 46033) announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2016, which apply from October 1, 2015 through September 30, 2016. The Federal Food, Drug, and Cosmetic Act … Continue Reading
