Regulatory

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.

GSK hopes $3-bil. off-label settlement will end legal woes

Marc Iskowitz November 07, 2011

GlaxoSmithKline's deal to resolve multiple US investigations into its sales and marketing practices—one of the largest settlements by a pharma company—aims to patch up several long-running legal disputes.

Omnicom, CAHG sign up for regulatory compliance training

Matthew Arnold November 04, 2011

Agency CAHG became the first healthcare marketing shop to undergo training and certification in regulatory compliance through the Center for Communication Compliance, and its parent company, Omnicom, said all of its healthcare agencies will follow suit.

IMS Health closes SDI deal, must divest two SDI product lines

Marc Iskowitz November 01, 2011

Federal regulators gave IMS Health the go-ahead to buy SDI Health, and IMS's parent company must now divest two SDI product lines.

Grassley blasts CMS foot-dragging on Sunshine Act

Matthew Arnold November 01, 2011

The Centers for Medicare and Medicaid Services, now a month overdue to issue draft guidelines for reporting pharma-physician contacts as required under healthcare reform legislation, said the department is working on it, but offered nothing in the way of a timeline.

Despite decline, ghostwriting in papers still common: study

Marc Iskowitz October 25, 2011

Researchers analyzing the prevalence of ghostwriting in leading medical journals over more than a decade saw a decline but found inappropriate authorship remained all too common.

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.

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.

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.

GSK revamps rep pay

Matthew Arnold July 05, 2011

On July 1, GlaxoSmithKline began pegging sales rep pay to a combination of "selling competency," customer evaluations and overall business unit performance instead of individual sales targets.

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.

Pharma digerati push for online guidelines

Matthew Arnold June 16, 2011

Frustrated by FDA inaction on guidance for digital marketing and social media, a host of industry players are banding together to form a nonprofit that can hammer out consensus on a way forward.

UK's drug promotion umpire issues internet guidance

Matthew Arnold April 13, 2011

The UK's Prescription Medicines Code of Practice Authority (PMCPA), which arbitrates drug industry self-regulation there, last week issued "informal guidance" on digital communications, and while it's more than FDA has offered, it's not much to go on.

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.

Data firms get a little help from their friends in Supreme Court case

Matthew Arnold April 04, 2011

The data mining firms fighting for their right to sell physician data got an assist as a host of big names, including a pair of former Health and Human Services secretaries, filed 16 supportive amicus briefs with the Supreme Court.

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.

Did the drug industry get a raw deal on healthcare reform?

Matthew Arnold March 22, 2011

The President signed the Patient Protection and Affordable Care Act into law on March 23, 2010. While the bill's gains, for industry and the uninsured alike, have yet to be realized, since the bulk of the law is set to go into effect in 2014, the pain to pharmas has been tremendous.

Market researchers wait for business to return to Minnesota

Marc Iskowitz February 15, 2011

Paying Minnesota physicians to participate in marketing surveys is no longer considered illegal, but tell that to pharmaceutical and medical device companies.