The United States Food and Drug Administration Prescription Drugs

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

FDA Panel Shows Strong Support for a Remicade Biosimilar

The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more

Health Care Outlook for 2016

In 2016, the Affordable Care Act will continue to be a contentious issue involving opposing legislative efforts and presidential debates. It has already been a major talking point in the campaigns of multiple 2016...more

Wyeth v. Levine’s ‘Clear Evidence' Language: Clearly Misunderstood

In 2009, the United States Supreme Court in Wyeth v. Levine affirmed a judgment rejecting a prescription drug manufacturer’s contention that plaintiff’s claim that the manufacturer should have strengthened its U.S. Food and...more

FDA-regulated industries: Plan now for these changes in 2016

In our last post, Life Sciences Decoded took a look at new food industry regulations that will roll out in 2016 under the FDA’s Food Safety and Modernization Act. But it’s not just the food industry that will need to prepare...more

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...more

FDA Regulatory and Compliance Monthly Recap — December 2015

Pacira secures expanded marketing for painkiller medication as FDA agrees to settle lawsuit, revoke warning letter - The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses,...more

“Destroying Things Is Much Easier Than Making Them” – The Worst Prescription Drug/Medical Device Decisions of 2015

In the original Hunger Games movie, while Katniss and Rue are plotting to blow up the Careers’ food stash, Katniss remarks that “destroying things is much easier than making them.” That’s how we feel about our bottom ten...more

New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion

In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic...more

Washington Healthcare Update

This Week: Congress unable to come to agreement on funding the government past Dec. 11 so a short-term funding bill was passed to give more time for negotiations... Tax extenders still being discussed as a vehicle for a...more

Health Care Update - December 2015

Cadillac Tax Repeal Garners Bipartisan Support; Prospects for Implementation Delay Increase - Last week, the Senate passed its reconciliation package by a vote of 52-47, sending it back to the House for approval and...more

Enbrel Biosimilar in Europe and US

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Benepali, the first biosimilar of Enbrel...more

Health Care Update - November 2015 #3

Drug Pricing Issues Heat Up Following HHS Forum - Last week, the Department of Health and Human Services (HHS) hosted a forum on prescription drug costs which featured players from every corner of the industry, including...more

A&B Healthcare Week in Review, November 2015

I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics....more

J & J Files Cert Petition in Massachusetts Supreme Court’s Unsupportable Rejection of Preemption Defense in Reckis TEN/Children’s...

Back in April, we blogged about the Massachusetts Supreme Court’s head-scratching rejection of defendants’ preemption defense in Reckis v. Johnson & Johnson, 471 Mass. 272, 2015 Mass. LEXIS 169 (Mass. April 17, 2015). As...more

FDA Approval of Addyi Sparks Debate

Is the controversial new drug touted as female Viagra cause for celebration or concern? Does the little pink pill represent “girl” power, or is it a shortsighted remedy for sexual dysfunction in women? Do its benefits...more

FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more

Health Care Update - November 2015

Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

Endo Pharms. Inc. v. Amneal Pharms. LLC

Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ. Nos. 12 Civ. 8115 (TPG), 12 Civ. 8060 (TPG), 12 Civ. 8317 (TPG), 12 Civ. 8985 (TPG), 13 Civ. 435 (TPG), 13 Civ. 436 (TPG), 13 Civ. 3288 (TPG), 13 Civ. 4343 (TPG), 13...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Can We Still Be Friends? FDA and Pacira to Settle Lawsuit Relating to Off-Label Promotion?

Taking a page (or lyric) from Todd Rundgren’s 1978 song, “Can We Still Be Friends,” it looks like the government, namely, the Food and Drug Administration and Department of Justice, and Pacira Pharmaceuticals, are looking to...more

Health Care Update - October 2015

Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

Merck Sharp & Dohme Corp. v. Sandoz Inc.

Case Name: Merck Sharp & Dohme Corp. v. Sandoz Inc., Civ. No. 3:12-cv-03289-PGS-LHG, 2015 U.S. Dist. LEXIS 113710 (D.N.J. Aug. 27, 2015) (Sheridan, J.) - Drug Product and Patent(s)-in-Suit: Emend® (fosaprepitant...more

BPCIA Statute: Has the Music Stopped or Will the Patent Dance Continue?

In July, a divided Federal Circuit issued a ruling in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499 appeal and held: (1) the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions...more

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

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