Government

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.

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.

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.

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.

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.

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.

Supremes strike down Vermont data law

Matthew Arnold June 23, 2011

The Supreme Court came down on the side of data firms, overturning a Vermont law banning the sale of prescription data to pharmas because it violates First Amendment speech protections.

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.

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.

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.

As GOP takes aim at FDA, Sharfstein bows out

Matthew Arnold January 04, 2011

The FDA's point-man on prescription drugs, principal deputy commissioner Joshua Sharfstein, is leaving amid Republican saber-rattling and promises of Congressional hearings on FDA.

Obama's FDA more responsive but still s-l-o-w, says industry

Matthew Arnold November 30, 2010

Drug and device firms feel FDA has provided better guidance under Obama, but remain frustrated over the slow pace of approvals, a PricewaterhouseCoopers survey found.

In GOP House victory, some relief for pharmas

Matthew Arnold November 03, 2010

Last night's Republican victories should make life easier for the industry in some respects - committee chairs with a pro-business bent and fewer subpoenas for CEOs to testify at inquests into industry evildoing, for example -- but first some sweet talk is in order.

Dendreon draws CBER letter for Provenge professional marketing

Matthew Arnold August 10, 2010

The Center for Biologics Evaluation and Research hit Dendreon with an untitled letter for false and misleading professional marketing materials for its prostate cancer treatment Provenge.

Business Roundtable chief to replace Tauzin at PhRMA

Matthew Arnold July 13, 2010

PhRMA named Business Roundtable chief John Castellani as its president and CEO, tapping a longtime trade association hand to replace former Congressional kingpin Billy Tauzin.

Allergan takes a page from the Tea Party with social campaign

Matthew Arnold May 17, 2010

Allergan is launching a policy-focused social media campaign promoting its lap-band weight loss surgery with a populist tinge.

Company News: Eli Lilly & Co.

March 25, 2010

Lilly chief John Lechleiter called for a shift in thinking on healthcare reform "from an emphasis on cost to an understanding of value ... and from thinking in terms of the broad population to focusing on meeting the needs of individual patients."

In the long run, reforms mean less risk, lower rewards for pharmas

Matthew Arnold March 23, 2010

In broad strokes, the healthcare reform bill that the president signed this noon holds much the same promise for pharmas as an SSRI does for depression or bipolar patients: less high highs, less low lows, more certainty and stability.

Aging Committee raps pharma on brand drug price hikes

Ben Comer March 18, 2010

Armed with AARP and Kaiser Family research, members of the Senate Special Committee on Aging asked panelists why brand drug prices in the US continue to increase, while other countries pay half as much for the same products.

DDMAC to get upgrade in reorg

Matthew Arnold February 25, 2010

DDMAC is being upgraded from a division to an office, an FDA official said yesterday.

Sharp Rx price jumps way up, says GAO

Matthew Arnold January 12, 2010

A Government Accountability Office study found "extraordinary price increases" in 416 branded drug products (across 321 brands) between 2000 and 2008. That's about half of one percent of all branded drug products.

Vermont pharma foe gets FTC nod

Matthew Arnold November 24, 2009

The nomination of former Vermont assistant attorney general Julie Brill to serve on the Federal Trade Commission would, if confirmed, be the latest of several appointments to give the healthcare industry pause.

Senate health bill pharma-friendly on biologics, price controls

Matthew Arnold November 19, 2009

The Senate health reform bill would maintain the ban on price controls in the Medicare prescription drug benefit and establish a 12-year data exclusivity period for biologics.