Prescription Drugs

News & Analysis as of

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat

On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug...more

Ohio Proposes New Telehealth Prescribing Regulations

The Ohio State Medical Board has proposed new telehealth prescribing regulations, which are predicated upon whether the drug is a controlled or not a controlled substance....more

A Step Forward in Approving Lower-Cost “Generic” Biologic Drugs

A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for...more

Generic Drug Manufacturers to Face Failure-to-Warn Claims in California

On January 20, 2015, the Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956, 2015 WL 231967 (U.S. Jan. 20,...more

Texas Torches Telemedicine? Board Issues Emergency Rule

The Texas Medical Board issued an Emergency Rule with proposed changes to the practice standards and disciplinary guidelines for remote prescribing via telemedicine consults. The Emergency Rule states that the use of online...more

De Novo Review of Claim Construction No Longer the De Facto Standard

On January 20, the U.S. Supreme Court, in Teva Pharmaceuticals USA, Inc. v. Sandoz, rejected the de novo review standard applied by the U.S. Court of Appeals for the Federal Circuit when reviewing all claim construction...more

Electronic Distribution of Prescribing Information for Prescription Drugs & Biologicals

The FDA published a proposed rule on December 18, 2014 that would require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

Speed of Pharmaceutical Innovation at Stake in N.Y. Antitrust Lawsuit

A pharmaceutical firm’s ability to efficiently produce and promote a better treatment for Alzheimer’s disease lies at the center of an antitrust lawsuit pending before the U.S. Court of Appeals for the Second Circuit. In...more

Lawsuits Piling up Against Makers of Risperdal, Invega

Antipsychotic Drugs Have Caused Breast Growth in Men - More than two years after Johnson & Johnson settled a lawsuit with a 21-year-old man who experienced an adverse side effect from Risperdal, hundreds of other young...more

Lawsuits Mount Against Xarelto as Pradaxa, Another Blood Thinner, Settles for $650 Million

Xarelto, a blood-thinning drug produced by Bayer Healthcare AG, has been hit with dozens of lawsuits as momentum picks up for possible mass tort litigation. The claims center on allegations that Xarelto drug makers didn’t...more

Pharmacy Qui Tam Based On U&C Price Billing Survives Motion to Dismiss

Once again, a pharmacy employee has filed a qui tam involving a drug discount program, alleging that the failure of the pharmacy to use the discounted pricing as the “usual and customary” price in Medicaid and Medicare Part D...more

When Is a Pharmacist Not a Pharmacist?

On January 14 the Texas Supreme Court will hear argument in an appeal that asks the question, When is a pharmacist not a pharmacist? The appeal is from a Texas Court of Appeals decision that answered the question this way: ...more

Stay Denied; Expedited Appeal Granted in Namenda Product Hopping Suit

Following the S.D.N.Y.’s award to the New York State Attorney General of an injunction requiring Actavis to continue distributing the immediate-release tablet version of its dementia drug, Namenda (which we analyzed...more

District Court Permits Section 2 Claim to Proceed Against Pharmaceutical Manufacturer for Denying Generic Rival Access to Branded...

On December 22, 2014, a federal district court in New Jersey found that Mylan Pharmaceuticals, Inc. (“Mylan”) alleged facts sufficient to plead an antitrust claim under Section 2 of the Sherman Act against defendant, Celgene...more

The Overuse of Antipsychotic Drugs in Nursing Homes

Many nursing homes are improperly prescribing antipsychotic drugs to patients even though federal law restricts their use. Almost 300,000 nursing home residents are currently receiving antipsychotic drugs normally used to...more

ODAC Committee Votes to License Sandoz’s Zarxio®

As noted in our previous client alert, FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act, Sandoz Inc. (“Sandoz”) filed the first biosimilar application under the Biologics...more

Second Circuit To Hear Expedited Appeal in “Product Hopping” Suit

On January 6, 2015, the Second Circuit granted defendants’ motion for an expedited appeal but denied their motion for a stay in New York v. Actavis PLC, 14-4624 (2d Cir. Jan. 6, 2015). Defendants are manufacturers of...more

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

New FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples?

Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the Orange Book, called the...more

Counties Seek To Implement Drug Disposal Ordinances

The Northern California County of Alameda has apparently begun to seek payment from select pharmaceutical manufacturers pursuant to the Alameda County Safe Drug Disposal Ordinance (Alameda County Code Chapter 6.53, §§...more

Cymbalta Withdrawal Cases May Soon Have an MDL

Eli Lilly & Co., the producer of the popular antidepressant Cymbalta (duloxetine), is facing a spate of litigation over injuries associated with the drug. Plaintiffs allege that Cymbalta can cause severe withdrawal symptoms,...more

Blog: No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human...more

Preliminary Injunction Order in Actavis Casts a Skeptical Eye Toward the “Hard Switch”

Last week, we briefly reported on the injunction granted by the U.S. District Court for the Southern District of New York in the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest...more

Lupin Appeals Fine Imposed by European Commission in “Pay-For-Delay” Crackdown

In July of this year, the European Commission imposed fines on French pharmaceutical company Servier and five generic drug makers, including Lupin Ltd., totaling €427.7 million. The fines were the result of a five-year...more

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