Policy

Must biosimilar names be distinct? No, experts argue

Must biosimilar names be distinct? No, experts argue

Innovator companies want the FDA to adopt separate names for biosimilars. Manufacturing changes aren't drastic enough to make it necessary, experts argued at an FTC workshop.

Docs haven't mellowed on DTC, snap poll suggests

Docs haven't mellowed on DTC, snap poll suggests

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The FDA wants to know how physician attitudes towards direct-to-consumer advertising have evolved since the agency last asked them, in 2002. If a snap poll by CMI/Compas is any indication, drug companies probably won't like the answers.

Q&A: BIO's Jim Greenwood

Q&A: BIO's Jim Greenwood

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BIO chief Jim Greenwood talks policy priorities and previews the group's International Convention, now underway in Chicago.

Obama budget would bleed pharmas

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The White House released its proposed budget for the 2014 fiscal year this morning, and while it gives a modest boost to Health and Human Services, it also seeks to extract more cost savings from pharmas.

For Obama's head-less CMS, third time's the charm

For Obama's head-less CMS, third time's the charm

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Acting administrator Marilyn Tavenner seems on track for confirmation, with the blessings of all industry stakeholders

Court could punt "Pay for Delay" back to Congress

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Eight members of the Supreme Court heard testimony in the case of FTC v. Actavis this morning, and the fate of so-called "pay for delay" settlements hangs in the balance.

Senate vote puts ACA's device tax in doubt

Senate vote puts ACA's device tax in doubt

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In a big win for the device industry, Senators voted overwhelmingly on a symbolic— but politically potent—motion to scrap the 2.3% device excise tax.

Congress loses a healthcare mover, and pharma an unlikely ally on IPAB

Congress loses a healthcare mover, and pharma an unlikely ally on IPAB

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The November elections were arguably the most important for healthcare policy in 40 years, cementing, as they did, the Affordable Care Act by awarding President Obama a second term. But with all eyes glued to the drama at the top of the ticket, many missed a major Congressional upset that could have big implications for healthcare policy.

The year ahead: A Capitol bit of crystal ball-gazing

From FDA and pharma, to Caronia and off-label communication, three healthcare policy experts offer their take on what 2013 holds in store.

Full steam ahead for Obamacare, but gridlock isn't going anywhere

Full steam ahead for Obamacare, but gridlock isn't going anywhere

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President Obama has cemented his greatest legislative achievement, the Affordable Care Act, but the status quo should prove anything but boring, with implementation of the law sure to mean more political fireworks

Voting with their wallets, pharmas say no thanks to change

Voting with their wallets, pharmas say no thanks to change

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Barack Obama edged Mitt Romney in fundraising from pharmas in the 2012 election, even as the industry favored Republicans in other contests. Were change-weary drug companies voting for the status quo?

Docs' presidential preferences follow practice type

Docs' presidential preferences follow practice type

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Solo practitioners favor Mitt Romney over Barack Obama by a two-to-one ratio, a survey finds, suggesting that changes in reimbursement driven by Obamacare are driving physicians' presidential preferences.

Sunshine Act could scare docs away from commercially-supported CME

Sunshine Act could scare docs away from commercially-supported CME

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Physicians are reconsidering their participation in industry-sponsored CME, fearful that their inclusion in Sunshine Act databases as having received payments from companies will tarnish their reputations and fuel perceptions of conflicts of interest, a survey has found.

HHS expands 9/11 health program to cover cancers

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The Department of Health and Human Services observed the anniversary of the September 11, 2001 attacks by extending coverage of a program for first responders sickened by their work at Ground Zero, the Pentagon and the Flight 93 crash site in Shanksville, PA to cover some 50 cancers.

Amid misspent billions, the promise of personalized medicine

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The Institute of Medicine has released a report putting the cost of unnecessary medical care at $750 billion a year and counting. What does it mean for pharmas? Depends on how you read it.

Healthcare takes center stage at political conventions

Healthcare takes center stage at political conventions

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Healthcare policy is having its day in the spotlight of presidential politics as Republicans and Democrats rekindle their sparring over the Affordable Care Act, Medicare and Medicaid.

Stryker layoffs blamed on Obamacare tax

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No sector of the healthcare industry is rooting harder for the Supreme Court to overturn the Affordable Care Act completely tomorrow than are medical device companies, which are bracing themselves for a substantial excise tax on their revenues that takes effect next year under the law.

In PhRMA-White House emails, little sizzle, less scandal

In PhRMA-White House emails, little sizzle, less scandal

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Congressional Republicans are trumpeting a cache of emails that give a glimpse into how the White House's deal with the pharma industry on healthcare reform came together. There's not much 'there' there, but there are some titillating glimpses into the legislative sausage factory.

PhRMA's Washington wish list

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PhRMA presented Washington with its legislative wish list - and a warning that plenty of other countries are trying to woo the industry away from the US.

Obamacare Court fail could hit pharmas with "double whammy"

Obamacare Court fail could hit pharmas with "double whammy"

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If the Supreme Court finds the "individual mandate" provision of the Affordable Care Act unconstitutional, as now seems surprisingly possible, the biopharma industry could be looking at a worst possible outcome situation.

Obamacare reconsidered: a pretty good deal for the drug industry

Obamacare reconsidered: a pretty good deal for the drug industry

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As the Supreme Court weighs the constitutionality of the Patient Protection and Affordable Care Act's "Individual Mandate"—and maybe the law itself—a pretty sweet deal for the drug industry hangs in the balance.

Congress takes a stab at IPAB

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Congressional Republicans -- and even a few Democrats -- are pressing the attack on the Independent Payment Advisory Board for Medicare, a part of the Affordable Care Act opposed by both PhRMA and the AMA.

Legislative wins, but no surety for survey researchers

Legislative wins, but no surety for survey researchers

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Quite a few states have moved to shield marketing research from regulation. The Supreme Court's ruling on healthcare reform could spur new threats.

Company news: FDA, Ranbaxy, Daiichi Sankyo and ImpactRx

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

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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

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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

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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

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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

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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

On fifth try, AMA ethics proposal becomes CME policy

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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.

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