Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more
11/10/2023
/ Cosmetics ,
Disclosure Requirements ,
Drug Compounding ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Costs ,
Manufacturers ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacist ,
Prescription Drugs ,
Reporting Requirements ,
Trademarks
U.S. health care attorneys, investors, and industry stakeholders are very familiar with the well-worn mantra that prescription drug and medical device companies are not allowed to “market” or “promote” their...more
Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts here and here Those looking ahead have...more
7/21/2022
/ Birth Control ,
Dobbs v. Jackson Women’s Health Organization ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Roe v Wade ,
SCOTUS
Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and...more
It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...more
It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more
9/13/2021
/ Biden Administration ,
Biosimilars Action Plan (BAP) ,
BPCIA ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
MedPAC ,
Pharmaceutical Industry ,
Prescription Drugs
Although we’ve now entered June of 2021 and President Biden has yet to nominate someone to serve as the Commissioner of Food and Drugs, current Acting Commissioner Janet Woodcock and her Senate-confirmed boss, Department of...more
In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more
12/28/2020
/ Biologics ,
Center for Biologics Evaluation and Research (CBER) ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Over The Counter Drugs (OTC) ,
Prescription Drugs ,
Vaccinations
It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The...more
11/9/2020
/ Controlled Substances ,
Controlled Substances Act ,
DEA ,
Due Diligence ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Recordkeeping Requirements ,
Substance Abuse ,
Wholesale
The U.S. Food and Drug Administration (FDA) recently announced what appears to be the first public warning made by the agency to a company promoting an approved prescription drug product for the unapproved use of treating...more
10/7/2020
/ Coronavirus/COVID-19 ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules
As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more
9/28/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Imports ,
Infectious Diseases ,
Medical Supplies ,
New Regulations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Secretary of HHS ,
Supply Chain
A panel of federal appellate judges has sided with drugmakers by upholding a lower court ruling from 2019 that struck down a regulation proposed by the Department of Health and Human Services (HHS). In a closely watched case,...more
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...more
6/10/2020
/ Abbreviated New Drug Application (ANDA) ,
Administrative Orders ,
CARES Act ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare Reform ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Rulemaking Process
At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more
12/30/2019
/ Code of Federal Regulations (CFR) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
FDA Commissioner ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Imports ,
NPRM ,
Popular ,
Prescription Drugs ,
Public Comment ,
Regulatory Requirements ,
Rulemaking Process ,
Secretary of HHS ,
Supply Chain ,
Trump Administration
This is our third year-end post for 2019 related to the Food and Drug Administration (FDA), focusing on the agency’s activities in the widely divergent area of “consumer products.” In taking a wide-lens view of the past year,...more
Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more
12/17/2019
/ Biosimilars ,
Biosimilars Action Plan (BAP) ,
Biotechnology ,
BPCIA ,
Clinical Trials ,
FDA Commissioner ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigational New Drug Application (IND) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Service Act ,
Regenerative Medicine ,
Regulatory Agenda ,
Regulatory Standards ,
Stem cells
Manufacturers and other drug developers should be cognizant of the fact that proper licensing is required in order to distribute prescription drugs. The process for obtaining a license to distribute often requires an...more
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more
9/17/2019
/ 21st Century Cures Act ,
Biologics ,
Biopharmaceutical ,
Drug Testing ,
FDA Reauthorization Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GAO ,
Institutional Review Board (IRB) ,
Investigational New Drug Application (IND) ,
Life Sciences ,
OMB ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Regulation ,
Right to Try
Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court. On August 21, 2019, the U.S. Department of Health and Human Services (HHS) filed a notice of appeal against a federal judge’s decision to...more
Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and Human Services (HHS) to prevent a new drug pricing disclosure rule from...more
7/2/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Commercial Speech ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Drug Pricing ,
Drug Wholesaling ,
Final Rules ,
First Amendment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Transparency ,
Trump Administration
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more
12/31/2018
/ 21st Century Cures Act ,
510(k) RTA ,
Biosimilars ,
CMMI ,
Comment Period ,
Cybersecurity ,
Digital Health ,
Draft Guidance ,
FDA De Novo Clearance ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Regulatory Agenda ,
Software Developers
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...more
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...more
7/20/2018
/ Anti-Competitive ,
Biosimilars ,
Competition ,
Drug Pricing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Innovation ,
License Applications ,
Pharmaceutical Industry ,
Prescription Drugs ,
Purple Book
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...more
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. Among others tackling...more
1/22/2018
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
Competition ,
FDARA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Notice Requirements ,
Orange Book ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain ,
User Fees