
FDA Regulatory
Viewpoints
Filter by:
FDA in 2020: What a Year!
December 15, 2020 | Blog | By Aaron Josephson, Benjamin Zegarelli
What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political pressure, and that effectively ensuring the public health requires a balance between safety and effectiveness and patient access to medical products. As we look ahead, we eagerly anticipate how FDA will protect and promote public health in a Biden administration. In this post we’ll explore the FDA’s device law and policy activities from 2020.
Read more
Beyond COVID: House Committee Advances Several FDA-Related Bills
July 23, 2020 | Blog | By Aaron Josephson, Margaret Jewett
Despite the COVID-19 pandemic, the House Energy & Commerce Committee continues work on several health policy issues, including Orphan Drug Act reform and continuous manufacturing.
Read more
OTC Monograph Reform: Key Takeaways and What Industry Can Expect
June 10, 2020 | Blog | By Benjamin Zegarelli, Elizabeth Conti, Joanne Hawana
On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph drugs. We previously blogged about the surprise addition of the OTC monograph reforms within the CARES Act. On May 29, 2020, the Office of Nonprescription Drugs within the Food and Drug Administration (FDA) held a webinar titled “Monograph Reform is Here!” (a recording of the webinar is available here), which included key highlights from the OTC monograph reform.
Read more
Coronavirus Relief Bill Includes Surprise Addition: OTC Monograph Reform Bill Becomes Law
March 30, 2020 | Blog | By Elizabeth Conti, Joanne Hawana
As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph teform bill into law on March 27, 2020. The passage of the OTC monograph reform bill is a surprise addition into the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the third COVID-19 stimulus bill enacted since the pandemic began. The reform legislation represents the first significant update to federal oversight of OTC drug products since 1972. It enables the Food and Drug Administration (FDA) to quickly respond to safety concerns and keep pace with innovation in hopes of protecting consumers from unsafe drugs and permitting manufacturers to market new products more expeditiously.
Read more
The VALID Act, Aiming to Reform the Regulation of Diagnostic Products, Is Finally Introduced in Congress
March 12, 2020 | Blog | By Aaron Josephson
Following years of discussion, on March 5, 2020, U.S. Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO) and U.S. Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced identical versions of the Verifying Accurate and Leading-edge IVCT Development (VALID) Act in both chambers of Congress. The bipartisan legislation closely tracks existing medical device laws, with some notable exceptions, discussed below and in a prior post. If enacted, many regulatory elements familiar to in vitro diagnostic (IVD) and other medical device manufacturers would be applied to clinical laboratories that develop their own tests, commonly known as laboratory developed tests (LDTs). The bill also includes elements that are priorities for the Food and Drug Administration (FDA), including a program conceptually similar to pre-certification, third-party review, and Collaborative Communities. Unlike previously-circulated discussion drafts, the introduced bills include specific language designed to address public health emergencies, including COVID-19.
Read more
FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round
February 3, 2020 | Blog | By Aaron Josephson
As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight some changes made to the programs when they were last reauthorized through the 2017 Food and Drug Administration Reauthorization Act (FDARA) (P.L. 115-52) and consider what could be included in the upcoming user fee reauthorization package.
Read more
FDA User Fees: How Do They Work?
January 28, 2020 | Blog | By Aaron Josephson
A history of FDA human medical product user fee programs, including those for prescription drugs (PDUFA), generic drugs (GDUFA), biosimilars (BsUFA), and medical devices (MDUFA), their negotiation and reauthorization, and how manufacturers and patients can participate and get involved in the negotiations.
Read more
Explore Other Viewpoints:
- Antitrust
- Appellate
- Arbitration, Mediation & Alternate Dispute Resolution
- Awards
- Bankruptcy & Restructuring
- Class Action
- Complex Commercial Litigation
- Construction
- Consumer Product Safety
- Cross-Border Asset Recovery
- Debt Financing
- Diversity
- EB-5 Financing
- Education & Nonprofits
- Employment, Labor & Benefits
- Energy & Sustainability
- Environmental Enforcement Defense
- Environmental Law
- FDA Regulatory
- Federal Circuit Appeals
- Financial Institution Litigation
- Government Law
- Health Care
- Health Care Compliance, Fraud and Abuse, & Regulatory Counseling
- Health Care Enforcement & Investigations
- Health Care Transactions
- Health Information Privacy & Security
- IP Due Diligence
- IPRs & Other Post Grant Proceedings
- Immigration
- Insolvency & Creditor Rights Litigation
- Institutional Investor Class Action Recovery
- Insurance & Financial Services
- Insurance Consulting & Risk Management
- Insurance and Reinsurance Problem-Solving & Dispute Resolution
- Intellectual Property
- Investment Funds
- Israel
- Licensing & Technology Transactions
- Life Sciences
- Litigation & Investigations
- M&A Litigation
- ML Strategies
- Medicare, Medicaid and Commercial Coverage & Reimbursement
- Mergers & Acquisitions
- Patent Litigation
- Patent Prosecution & Strategic Counseling
- Privacy & Cybersecurity
- Private Client
- Private Equity
- Pro Bono
- Products Liability & Complex Tort
- Project Development & Finance
- Public Finance
- Real Estate Litigation
- Real Estate Transactions
- Real Estate, Construction & Infrastructure
- Retail & Consumer Products
- Securities & Capital Markets
- Securities Litigation
- Sports & Entertainment
- Strategic IP Monetization & Licensing
- Tax
- Technology
- Technology, Communications & Media
- Trade Secrets
- Trademark & Copyright
- Trademark Litigation
- Venture Capital & Emerging Companies
- White Collar Defense & Government Investigations