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Manufacturers Pharmaceutical Industry The United States Food and Drug Administration

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

by Mintz Levin on

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

Louisiana Adopts Price Reporting Law

by Kelley Drye & Warren LLP on

A new law in Louisiana requires drug manufacturers to report wholesale acquisition cost (WAC) information directly to the state. Louisiana law defines WAC as “the manufacturer’s list price for the pharmaceutical drug or...more

Adverse Event Reports for Food, Supplements and Cosmetics Are Now Publicly Available: What Manufacturers Need to Know

by Pepper Hamilton LLP on

Enhancing transparency has been one of the FDA’s top priorities for nearly a decade. In late 2016, the agency continued to advance this goal by publishing data relating to food, cosmetics and dietary supplements from its...more

Medical Device Security: FDA Releases Final Guidance On Interoperable Medical Devices

by Reed Smith on

On September 6, 2017, the FDA issued its final guidance on “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices.” This Guidance is intended to address the tension between...more

AGG Food and Drug Newsletter - October 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Product Liability Update: October 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

I Won’t Back Down: Another Company Refuses to Permit FDA to Inspect

by Arnall Golden Gregory LLP on

Not long ago, we wrote about a company that refused to permit an FDA investigator to conduct an inspection. Well, here we go again. Apparently a fan of the late, great Tom Petty, the company told the agency, “I won’t back...more

New California Law Limits Drug Manufacturer Co-Pay Cards and Other Discounts in California

by Hogan Lovells on

In the most recent salvo by states eager to show an effort to contain prescription drug costs, California's governor has signed into law a bill that will prohibit, with some limited exceptions, pharmaceutical manufacturers...more

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter...more

FDA Clarifies Trading Partners Under the DSCSA

by Reed Smith on

The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with...more

FDA Issues Guidance on Hurricane Readiness for Medical Devices

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices. FDA stresses that during hurricanes and other emergency situations, medical devices...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

FTC Competition Director Highlights Enforcement Priorities in the Pharmaceutical Industry

Last week Markus Meier, the Acting Director of the Bureau of Competition at the Federal Trade Commission, gave testimony to the House Judiciary Committee concerning “Antitrust Concerns and the FDA Approval Process.” ...more

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

by Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

Reversal of $48 Million Product Liability Verdict Required Due to Inconsistent Jury Findings on Failure to Warn Claims and...

In Trejo v. Johnson & Johnson, et al. (No. B238339, filed 6/30/2017), the California Second Appellate District held, among other things, that the jury’s finding that defendant was liable for negligent failure to warn was...more

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

by Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

Continuous Manufacturing of Pharmaceuticals: FDA Wants to Hear from Industry

by Hogan Lovells on

Continuous manufacturing has often been highlighted by FDA as an exciting technology in the area of pharmaceutical manufacturing, but one that the Agency is still wrapping its head around. Accordingly, on June 22, 2017, FDA...more

Filling in the Gaps on Medical Device Cybersecurity

by Hogan Lovells on

Cybersecurity has become a hot button topic for many in the medical device industry following the announcement of several high-profile medical device vulnerabilities and in light of the recent WannaCry ransomware attack that...more

Things That Make You Go Hmmm, Part II: Drug Company Plays Games With FDA To Delay Facility Inspection

by Arnall Golden Gregory LLP on

More than ten years ago, I wrote an article about a company action that invoked a memory of my then-3-year old son’s playful “The Thinker” pose. (I continue to have this picture hanging in my office now.) He would frequently...more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

Non-Existent Duty to Warn of Mensing Not Enough to Get Around Mensing Preemption

by Reed Smith on

Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal. Part of why the defendant drug or device manufacturer may prefer federal...more

Blog: Compliance Date for Drug Supply Chain’s Security Act’s Serialization and Verification Requirements Quickly Approaching

by Cooley LLP on

Manufacturers must begin to comply with the Drug Supply Chain Security Act (DSCSA) serialization and verification requirements on November 27, 2017 (Compliance Date). Serialization and verification are intended to enable...more

FDA Is Cold As Ice As It Steps Up Foreign Inspection Enforcement

by Arnall Golden Gregory LLP on

So far, in 2017, the Food and Drug Administration’s Office of Manufacturing Quality in the Center for Drug Evaluation and Research has released fourteen Warning Letters. Of these, 100% involved manufacturing facilities...more

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