October 17, 2018| Blog
In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and biological products, the Agency is recommending that companies take additional steps to ensure that quantitative efficacy or risk information does not convey inaccurate information and does not have the potential to confuse consumers. The draft guidance defines quantitative efficacy and risk information as “information that numerically addresses the likelihood or magnitude of a drug’s effectiveness or risks.” FDA’s advice on how to most clearly share this type of information should be considered by companies when developing any form of DTC promotional media, whether they are digital, broadcast, in traditional print format, or otherwise.
October 15, 2018| Blog
Congress has left town until after the midterm elections, but the Administration is continuing to advance its priorities in the regulatory arena. This week, the Administration is expected to publish the proposed rule, "Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency." We cover this and the political implications in this week's health care preview.
October 2, 2018| Blog
Regulatory compliance is often treated as completely independent from development or enforcement of patent rights. This situation is not helped by the absence of coordination between the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO). Still, companies must understand and appreciate the impact regulatory submissions may have on their patent portfolio.
July 24, 2018| Blog
In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and agency action” related to drug pricing issues.
July 24, 2018| Blog
As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018 to gather stakeholder input on “FDA’s approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.”
July 19, 2018| Blog
On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for stimulating and improving the marketplace for biosimilars in the U.S.
FDA Releases Series of Gene Therapy Guidance Documents: From Drug Development to Postmarket Monitoring
July 11, 2018| Blog
In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval of gene therapy products on July 11, 2018.
June 20, 2018| Blog
A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory program for biosimilar products and the abbreviated BLA (aBLA) review process.
May 21, 2018| Blog
This week, the House is set to vote on Right to Try legislation which has gained the support of FDA Commissioner Scott Gottlieb. In the Senate, the HELP Committee will review the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, or PAHPA, along with rural health care issues, which the Senate Finance Committee also happens to be looking at this week.
May 14, 2018| Blog
Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a roller coaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago.
April 18, 2018| Blog
In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance.
April 13, 2018| Blog
Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain.
March 7, 2018| Blog
On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act (P.L. 111-148, Sec. 6002, amending Social Security Act Sec. 1128G), also known as the Physician Payments Sunshine Act (PPSA).
NDA/ANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book
January 18, 2018| Advisory
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years.
July 12, 2016| Alert
Building on last year’s public workshops related to Next-Generation Sequencing (NGS) and expanding its efforts to advance the Obama Administration’s Precision Medicine Initiative, the FDA late last week released two draft guidance documents on different aspects of NGS-based diagnostic tests.
February 2, 2016| Blog
Mintz Levin’s Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation on the Biologics Price Competition and Innovation Act (“BPCIA”) and its implementation.
July 21, 2015| Alert
The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company with offices in France and New Jersey, regarding the company’s conduct as a sponsor of several clinical trials is noteworthy.
FCC Modifies Cost Recovery Rules for Medical Device Tests and Proposes Greater Access to MedRadio Bands for Testing
July 13, 2015| Advisory
On July 6, 2015, the Federal Communications Commission (“FCC”) adopted a Memorandum Opinion and Order modifying its rules covering Experimental Radio Service (“ERS”) licenses, which permit research and testing of radio equipment.
Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic Requirements for Promotional Communications
June 23, 2015| Advisory
For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s prescription drug advertising regulations, along with FDA’s interpretations of the law as put forth in guidance documents and warnings to industry.
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