May

Even Without Increased Authority, FDA Steps Up Enforcement Of Compounding Pharmacies

Courtney A. Stevens | Staff Attorney, Medmarc Loss Control

Although there are current efforts making their way through the legislative process to statutorily enhance the FDA’s authority and oversight over compounding pharmacies, the Agency has already stepped up its enforcement of the entities under the existing regulatory framework. The FDA does already have authority to perform inspections of compounding pharmacies under the Federal Food, Drug, and Cosmetic Act (FDDCA) and has been exercising that authority at a record pace since the New England Compounding...

May

Life Sciences News Roundup, 5/7

Courtney A. Stevens | Staff Attorney, Medmarc Loss Control

Three Hard Lessons Learned from Relations with Chinese Suppliers – MD+DI (free subscription required)
FDA Flexing its Muscle with Compounding Pharmacies – Product Liability Monitor
The Luck Factor for New Medical Devices – Mass Device
How to Select the Best Clinical Trial Sites – MedCity News (IMARC)

April

Life Sciences News Roundup, 4/26

Courtney A. Stevens, Esq. | Staff Attorney, Medmarc Loss Control

FDA Says That It Knows That the Clock Is Ticking on Internet and Social Media Guidance – Drug and Device Law Blog
China’s Proposed Regulations on Medical Devices - What Should American Device Companies Know? – Medical Device CRO Blog
Localization, Language Strategies Are Key to Emerging Market Success – Pharmaceutical Compliance Monitor
Rebuilding the Medtech Engineer – European Medical Device Technology
Pharmas to Biotechs: Let's Make a Deal – Medical Marketing & Media

April

Litigation Update: Generic Pharmaceuticals and Failure-to-Warn Claims

Courtney A. Stevens | Staff Attorney, Medmarc Loss Control

Bartlett Argument

Last month, the Supreme Court heard argument in Mutual Pharmaceutical Co. v Bartlett. The outcome of this case is of huge import to generic drug manufacturers, who may get the long-awaited reprieve from state-law-based, failure-to-warn claims that many Prescription med bottles 2.jpg thought they were in for after the Court's decision in Mensing. (Mensing held that federal law preempted state-law-based, failure-to-warn claims against generic drug manufacturers, because federal law required generic drugs to bear...

April

Life Sciences News Roundup, 4/1

Courtney A. Stevens | Staff Attorney, Medmarc Loss Control

OIG Issues Special Fraud Alert on Physician Owned Distributorships (PODs) – FDA Law Blog
Seriously, What is Going On at the Office of Combination Products? – MD+DI Device Talk
Argentina Updates General Law for Medical Devices – Aptiv Solutions Medical Device Blog
Sunshine Act Final Rule is Finally Here: Prepare to Comply – Pharmaceutical Compliance Monitor

March

Life Sciences News Roundup, 3/18

Courtney A. Stevens | Staff Attorney, Medmarc Loss Control

Do Device Companies Have it Worse Then Pharma? – Medical Device CRO Blog
Surgery Clinical Trial Results Selectively Reported – MedCity News
The Solution To Pain Killer Addiction: Litigation – Abnormal Use
U.S. vs. Caronia: What are the Implications? – Pharma Compliance Monitor
Supreme Court to Hear Arguments Over Generic Drugmaker Liability Tomorrow – Thomson Reuters (Note: Medmarc’s own Sara Dyson and Karen Murphy will be attending the argument at the Supreme Court.)

March

More Potential Perils of Social Media for Drug and Device Companies

Courtney A. Stevens, Esq. | Staff Attorney, Medmarc Loss Control

FDA Cites Inappropriate Facebook “Like” in Warning Letter

A recent Warning Letter illuminates yet another potential pitfall of life sciences companies’ use of social media. The Letter comes down on supplement maker AMARC Enterprises, Inc. for alleged off-label promotion, done mostly through the posting of customer testimonials on the company’s website.

Among the list of offending testimonials the Letter cited was one unusual mention: a Facebook post by a purported user of AMARC’s drug, “Poly MVA.”...

February

Life Sciences News Roundup, 2/27

Courtney A. Stevens, Esq. | Staff Attorney, Medmarc Loss Control

FDA’s Unique Device Identifier Program is a Prince Masquerading as a Frog – MD+DI
What Can Pharmaceutical Companies Expect From the FDA and CMS, the States and Congress? – Pharmaceutical Compliance Monitor
How Can the Weather Impact Medical Devices? – Medical Device CRO Blog
J&J Must Pay $3.35 Million to Patient in Vaginal Mesh Case – Mass Device

February

Potentially Adverse Effects of Tort Reform on Life Sciences Companies

Courtney A. Stevens, Esq. | Staff Attorney, Medmarc Loss Control

Many conceive of tort reform as targeting and reducing jury awards that shock the conscience—the multi-million dollar verdicts for slip-and-fall accidents, “hot-coffee” cases, and minor injuries from allegedly defective products or medical malpractice, for Justice sign on building.jpg example. In that many tort reform efforts place limits on non-economic and punitive damages, this conception rings true. However, there is an oft-ignored aspect of tort reform that can result in an unfair shifting of the burden of award payments....

February

Life Sciences News Roundup, 2/14

Courtney A. Stevens, Esq. | Staff Attorney, Medmarc Loss Control

Medical Device Tax: Impact on Manufacturers and Importers – Medical Device Summit (free subscription required)
FDA’s Plan for Speeding 510(k)s: Triage for 90-Day Decisions – MD+DI
Interactive Map Compares Hospital Readmission Rates Nationwide - MedCityNews
The Bright Side of the Sunshine Act – The Pharma Compliance Blog
Home Use Device Draft Guidance: Key Points and Request for Comments – Medical Device Summit (free subscription required)

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