FDA

Industry group releases digital best practices

Matthew Arnold February 06, 2012

Weary of FDA foot-dragging on digital and social media guidance for pharmas, a group of 60-some industry digerati have put together guidelines of their own.

FDA study casts doubt on danger of "distracting visuals"

Matthew Arnold January 31, 2012

An FDA study looking at the power of background visuals to distract viewers from the often-ominous risk info read in the "major statement" section of TV drug ads found no evidence that consumer understanding of risk info is affected by the "emotional (affective) tone of images.

FDA gives guidance on brand, generic names in ads

Matthew Arnold January 26, 2012

The FDA issued guidance clarifying narrow questions of scientific or generic name placement in ads and labeling in different media, including electronic media.

Tysabri gets boost from label change, new diagnostic

Deborah Weinstein, Marc Iskowitz January 23, 2012

Biogen Idec and Elan, which market Tysabri for multiple sclerosis, won approval to add new safety information to the drug's label that could boost sales by helping doctors avoid a serious adverse event.

Company news: Gilead, Pfizer and Wolters Kluwer

December 29, 2011

Two potential blockbusters in the pharma pipeline took another step toward reaching market, as US regulatory authorities assigned PDUFA dates for Gilead Sciences' Quad pill and for Pfizer's tofacitinib.

DOJ hit pharmas for $2.2 billion in 2011 False Claims Act cases

Matthew Arnold December 20, 2011

Pharmas shelled out $2.2 billion in False Claims Act fines and settlements with the Justice Department this year as the feds' healthcare fraud haul hit an all-time high.

How Genentech cut journal ads across all Avastin indications

Marc Iskowitz December 05, 2011

Well before the FDA revoked Avastin's approval in breast cancer, Roche's Genentech unit deeply cut the professional media plan for the drug, the company said.

Since Vioxx scare, tough times for industry R&D, study finds

Matthew Arnold December 01, 2011

A review of 450 New Molecular Entities spanning a decade and a half found two distinct eras of drug R&D - one of abundance and one of scarcity, hinging on the September, 2004 withdrawal of Merck's Vioxx.

Merck wraps up Vioxx litigation with feds, states: $1b in fines, new CIA

Matthew Arnold November 22, 2011

Seven years after the biggest drug safety scandal since thalidomide was found to cause birth defects, Merck and the Justice Department announced a nearly $1 billion settlement of litigation over Vioxx, the Cox-2 pain drug found to cause strokes and heart attacks.

Par Pharma suit could set up off-label court showdown

Matthew Arnold October 18, 2011

Par Pharmaceutical last week asked a federal court to tell the FDA to back off and allow the company to detail docs about using its Megace ES to treat AIDS-related wasting.

Company news: FDA, Ranbaxy, Daiichi Sankyo and ImpactRx

October 06, 2011

The FDA issued Driving Innovation, a blueprint for fostering American biomedical innovation, reiterating a prior commitment to reform regulation and announcing policies aimed at facilitating personalized medicine.

Say so long to DDMAC as FDA's OPDP levels up

Matthew Arnold September 19, 2011

The FDA gave its Office of Medical Policy a long-awaited org chart upgrade, making it a "super office" and giving the department formerly known as the Division of Drug Marketing, Advertising and Communication, or DDMAC, a new acronym: OPDP.

FDA, industry agree on PDUFA deal to speed NME reviews

Matthew Arnold September 01, 2011

The FDA and the biopharma industry have agreed in principle on a revamp of the Prescription Drug User Fee Act (PDUFA), by which pharmas provide nearly two-thirds of what the agency spends on drug reviews.

Pfizer's Xalkori and Abbott test show promise in personalized medicine, companion diagnostics

Matthew Arnold August 30, 2011

The FDA's approval of Pfizer's Xalkori (crizotinib) represents a leap forward for both personalized medicine and Pfizer's R&D turnaround, but its commercial success hinges on a pricey diagnostic array by Abbott's Vysis.

FDA to IOM: More work? No thanks

Matthew Arnold August 11, 2011

The FDA is moving cautiously on a call by the Institute of Medicine to scrap the approvals process for many medical devices.

Pain for pharmas in debt ceiling deal

Matthew Arnold August 02, 2011

The 11th-hour debt ceiling deal now squeaking through Congress will likely mean some pain for the drug and device industries, along with everyone else.

Brilinta boosts AstraZeneca, but can it carry them over the cliff?

Matthew Arnold July 21, 2011

The FDA gave the green light to AstraZeneca's Brilinta (ticagrelor) anti-platelet for heart attack prevention, but the brand will carry a black box warning, a Risk Evaluation and Mitigation Strategy requirement and an obligation to educate doctors about possible risks of use in users of high-dose aspirin.

FDA guidance exempts most pharma apps from scrutiny

Matthew Arnold July 19, 2011

FDA issued draft guidance on mobile medical apps, focusing narrowly on those programs that augment regulated medical devices or turn mobile devices into medical devices.

FDA reorg puts an industry veteran in charge of drugs

Matthew Arnold July 14, 2011

FDA Commissioner Margaret Hamburg named a former Merck and J&J scientist to the new post of deputy commissioner for medical products and tobacco as part of a sweeping reorganization of the agency's management structure.

Pharmas ask FDA for guidelines on off-label info

Matthew Arnold July 06, 2011

Seven large pharmas filed a citizen petition with FDA asking for guidance on communication about off-label uses for products.

FDA weighs brief summary format redesign

Matthew Arnold June 21, 2011

The FDA is weighing shifting to a prescription drug brief summary format more like that of the "Drug Facts" design used for OTC products, based on a study showing that it led to higher risk comprehension.

Vertex versus Goliaths in HCV drug duel

Matthew Arnold May 23, 2011

Vertex has succeeded in bringing one heck of a new drug to market in Incivek (in-SEE-veck, or telaprevir), a hepatitis C drug 15 years in the making which promises to cut treatment time in half. Selling the drug against the combined might of Roche and Merck could be nearly as tricky.

FDA to probe website DTC risk/benefit presentation

Matthew Arnold April 28, 2011

The FDA announced plans to study online consumer advertising for prescription drugs in order to resolve "a number of questions surrounding how to achieve 'fair balance' in online DTC promotion.

Speedier drug review tops pharma's PDUFA wish list

Marc Iskowitz April 12, 2011

The biopharma industry, in talks this year with the FDA over user-fee laws set to be renewed by Congress, is said to be nearing agreement on a package of recommendations.

Social media "power users" favor letting companies socialize, survey finds

Matthew Arnold April 05, 2011

Social media "power users" value interaction with healthcare companies want them regulated but around, according to a WEGO Health survey.

FDA again delays promised social media guidance

Matthew Schwartz March 30, 2011

The FDA has once again postponed the release of its first draft guidance for social media.

DC MDs Dean and Frist talk healthcare reform and biopharma

Marc Iskowitz March 29, 2011

There isn't much in the Affordable Care Act to cut healthcare costs, agreed former senator Bill Frist (R-TN) and ex-governor Howard Dean (D-VT), both of whom came to politics with MDs instead of JDs. But the law has led to a serious national discussion on reducing expensive care and, combined with measures supporting the biopharma industry, could set the stage for reining in US healthcare spend, they agreed.

FDA approves BMS skin cancer biologic Yervoy

Matthew Arnold March 25, 2011

The FDA approved Bristol-Myers Squibb's cancer biologic Yervoy (ipilimumab) for the treatment of late-stage melanoma, a particularly deadly form of skin cancer for which treatment options are few. One analyst projected that sales of the drug could top $1.7 billion by 2015.

To dial down DTC, let companies collaborate on ads, says ex-Merck exec

Matthew Arnold February 10, 2011

A former Merck exec says it's time to wind down the DTC arms race by letting companies with brands in competitive categories collaborate on disease awareness advertising.

FDA unveils transparency steps for regulated industries

Matthew Arnold January 06, 2011

FDA's Joshua Sharfstein, on his way out the door, unveiled Phase 3 of his FDA Transparency Initiative - the part aimed at making the agency more responsive to regulated industries.