Tag Archives: FDA

Public Health Bills Advance

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

FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products

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

Senate HELP Committee Completes Work on Bipartisan “Cures”/Medical Innovation Legislation

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

Senate HELP Committee Approves Additional Biomedical Innovation Bills

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

Senate HELP Committee Clears Bipartisan Biomedical Innovation, Health IT Bills

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

FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices

On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks.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

Senate HELP Committee Outlines Plans for Action on Biomedical Innovation Bills

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

FDA Public Workshop on Patient, Medical Professional Perspectives on Receiving Genetic Test Results (March 2)

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 Signs Bill to Restrict Use of Microbeads in Cosmetics

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

FDA to Hold Medical Device Cybersecurity Workshop (Jan 20-21)

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

Congress Clears Controlled Substances Act Scheduling Legislation

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

Upcoming Health Policy Hearings

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

Agencies Release Proposed Overhaul of the Common Rule

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

FDA Issues New Draft Guidance and Related Proposed Rule on Naming Biological Products

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

FDA Announces Medical Device User Fee Rates for Fiscal Year 2016

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

FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages

On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule implements provisions of the Food and Drug Administration Safety and Innovation Action of 2012 (FDASIA) (Pub. L. No. 112-144). … Continue Reading

FDA Requests RSVP for Public Meetings on PDUFA Reauthorization

The federal Food and Drug Administration (FDA) has issued a notice requesting that public stakeholders –including patient and consumer advocacy groups, health care professionals, and scientific and academic experts– notify FDA of their intent to participate in monthly consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). When the statutory authority … Continue Reading

FDA Helps Dispensers Enjoy the Summer with Generous DSCSA Compliance Policy

The federal Food and Drug Administration (FDA) just announced that the Drug Supply Chain Security Act (DSCSA) deadline of July 1, 2015 for dispenser requirements related to capturing and maintaining pedigree information will not be enforced until November 1, 2015. This means dispensers have an additional four months to establish a commercially-viable and operational system that … Continue Reading

Revised House 21st Century Cures Bill Released Ahead of House Vote

Later this week, the House of Representatives is expected to consider the H.R. 6, the 21st Century Cures Act.  Ahead of the House vote, the House Rules Committee released a revised version of the bill with new funding offsets and other policy changes.  Notably changes in the newest version include: A provision excluding authorized generics … Continue Reading

House Energy and Commerce Committee Unanimously Approves 21st Century Cures Bill

Today the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability … Continue Reading

FDA Issues Three Biosimilar Final Guidances

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are intended to clarify both scientific and regulatory considerations for a broad range of stakeholders, including drug companies, in manufacturing biosimilars. … Continue Reading

OIG Assesses FDA Progress on Oversight/Inspections of Generic Drug Manufacturers

In a recent report, the HHS OIG concludes that FDA has made progress in improving oversight of generic drug manufacturers, including greater parity in inspections of foreign and domestic generic drug manufacturers. A summary of the report, FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs, is available on our Life Sciences … Continue Reading