Searching Content indexed under Food and Drugs Law by Mintz ordered by Published Date Descending.
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HHS Files Brief In D.C. Circuit Supporting Drug Pricing Transparency Rule
As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court's
United States
8 Oct 2019
FTC Identifies Concerns With Plaintiff's Lawyers Advertisements Concerning Risks Associated With Pharmaceutical Drugs
I suspect that we've all had this experience. You've finished a long day of work, had dinner, and have cozied up on the couch with a glass of wine to watch a re-run of your favorite TV show.
United States
4 Oct 2019
GAO Report Sheds Light On Drug Manufacturers' Expanded Access Programs
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...
United States
23 Sep 2019
GAO Studies Use Of PBMs In Medicare Part D
GAO recently released a report analyzing the use of pharmacy benefit managers ("PBMs") and efforts to manage drug spending and use in the Medicare Part D program
United States
28 Aug 2019
HHS Drug Pricing Disclosure Rule: Chance At A Renewed Life Following District Court Appeal?
Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court.
United States
28 Aug 2019
Congress Looking To Streamline CBD Drug Research
We've previously blogged about the regulation of CBD by the Food and Drug Administration (FDA), and it appears that the dialogue around CBD
United States
16 Aug 2019
CMS Takes Another Swing At 340B Reimbursement Cuts. Will It Be Strike Three?
The proposed 2020 Outpatient Prospective Payment (OPPS) rule was published on August 9, 2019. Buried in the 819 pages of proposed changes and justifications
United States
15 Aug 2019
Open Payments Program Expansion
On July 30, 2019, the Centers for Medicare & Medicaid Services ("CMS") announced more proposed changes to the Open Payments Program.
United States
13 Aug 2019
In Policy Reversal, HHS And FDA Propose Plan To Import Foreign Drugs
On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan
United States
12 Aug 2019
Senate Finance Committee Passes Drug Pricing Bill
Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest
United States
5 Aug 2019
ML Strategies Health Care Preview - Week Of July 29, 2019
This week, the Senate is expected to consider the House-passed two-year budget deal that will also suspend the debt limit for two years.
United States
2 Aug 2019
FDA Invites Compounding Outsourcing Facilities' Comments To Understand Industry Challenges And Opportunities
On July 29, 2019, the Food and Drug Administration (FDA) published a notice to the Federal Register (84 Fed. Reg. 36609).
United States
2 Aug 2019
Software Update: The Latest On FDA's Pre-Cert Pilot
Regular readers of this blog know that we're closely following the FDA's proposed regulatory framework for software as a medical device (SaMD), known as precertification
United States
26 Jul 2019
Trump Administration Withdraws Proposed Rebate Rule
In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor
United States
19 Jul 2019
Third Circuit Dismisses FCA Case Under Pre-ACA Version Of Public Disclosure Bar
The Third Circuit Court of Appeals recently dismissed a relator's False Claims Act ("FCA") case under the pre-Affordable Care Act ("ACA") version of the public disclosure bar.
United States
18 Jul 2019
Federal Judge Strikes Down Hhs Drug Pricing Disclosure Rule
In follow-up to our previous post, the pharmaceutical industry gained a win on July 8th when a federal judge struck down the Trump administration's rule
United States
17 Jul 2019
ML Strategies Health Care Preview: ACA Oral Arguments To Begin
Welcome back. This week, the Senate Finance Committee is set to meet privately to discuss the drug pricing legislation being developed by the committee
United States
16 Jul 2019
Pharmaceutical Companies Object To HHS Drug Pricing Disclosure Rule
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...
United States
4 Jul 2019
OIG Report Finds A Small Percentage Of Hospitals Do Not Obtain Compounded Drugs From FDA-Registered Outsourcing Facilities
On June 6, 2019, the U.S. Department of Health and Human Services' Office of Inspector General issued a report that found that, among a sample U.S. hospitals that obtained non-patient-specific compounded drugs ...
United States
21 Jun 2019
Heritage Pharmaceuticals Admits To Generic Drug Price Fixing Scheme
The May 30th charge is not Heritage's first brush with DOJ's generic price-fixing investigation.
United States
21 Jun 2019
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