Policy

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.

ACCME punts on proposed logo ban

Marc Iskowitz August 16, 2011

Corporate logos may still appear in CME commercial support disclosures, ACCME said, after a majority of respondents expressed disapproval of its proposal to ban them.

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 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.

On fifth try, AMA ethics proposal becomes CME policy

Marc Iskowitz June 23, 2011

A new report passed by AMA delegates draws ethical boundaries around the use of industry funding for medical education, stopping well short of the all-out ban seen in some previous versions.

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.

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.

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.

Renewed focus on Alzheimer's could help new drugs to market

Ben Comer December 16, 2010

The House's passage of the National Alzheimer's Project Act yesterday - should it be signed into law by President Obama - could help expedite the approval process for new drugs targeting the disease, sources say.

Company news: AstraZeneca

December 02, 2010

AstraZeneca chief David Brennan said the company will see nearly a billion dollars shaved off its profits for 2010 and 2011 combined due to healthcare reform legislation in the US, Reuters reported.

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.

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.

Tauzin steps down as reform goes off the rails

Matthew Arnold February 12, 2010

Billy Tauzin is stepping down as head of PhRMA amid speculation that the derailment of healthcare reform has empowered an anti-reform faction within the group. Tauzin, who has moved the group toward the Democrats and negotiated with the White House over the legislation, will leave PhRMA at the end of June.

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.

ACCME ponders naming and shaming

Marc Iskowitz November 12, 2009

The ACCME said it will consider releasing names of providers and activities found to violate bias rules. The exact details of the disclosure, if any, and the timing are under review by the ACCME Board of Directors, which meets December 3-4.

Physician's group wants new drug labeling, 2-year DTC moratorium

Matthew Arnold September 25, 2009

The American College of Physicians called for the FDA to be empowered to label newer drugs as such and to restrict consumer advertising of them.

PhRMA, friends air $12m pro-reform TV spot

Matthew Arnold August 13, 2009

The first execution in PhRMA's promised pro-health reform campaign -- a $12 million TV spot aimed at communicating how the legislation will impact individuals -- airs today