AstraZeneca: Unwitting Advocate for Disclosure?

Erik Greb PharmTech editorHealthcare-reform legislation is not the only federal initiative that is affecting pharmaceutical manufacturers these days. US Attorney General Eric Holder is cracking down on healthcare fraud, including false claims against Medicare and Medicaid. AstraZeneca (London) felt the sting of Holder’s campaign when it agreed last week to pay $520 million to resolve accusations that it marketed its atypical antipsychotic Seroquel illegally. Read more »

Pfizer Fights Transparency

Erik Greb PharmTech editorPatients rely on doctors to make impartial decisions about the most effective treatments for their conditions. In recent years, public advocates have agitated for restrictions on pharmaceutical companies gifts’ (e.g., meals, honoraria, or entertainment) to medical professionals on the grounds that they could unduly influence prescribing habits. In what seems like a fight against transparency, Pfizer (New York) sent employees to Connecticut’s capitol to protest a state bill that would restrict such gifts and require reporting. Read more »

Will Comparative Effectiveness under Healthcare Reform Change Drug Development?

Patricia Van Arnum PharmTech editor One week after President Barack Obama signed the Patient Protection and Affordable Care Act (HR 3590), the sweeping healthcare reform legislation into law (Public Law No. 111-148), it is still an important task to evaluate the impact of the new law on the pharmaceutical industry. Last week we reported and commented on some of those implications, and this week we continue our analysis: provisions in the new legislation regarding comparative effectiveness research (CER) and the underlying shift to value-based healthcare. Read more »

Healthcare Reform Passes Final Legislative Hurdle, So What’s Next?

Patricia Van Arnum PharmTech editor The legislative battle for healthcare reform ended on Thursday night Mar. 25 following the passage by both houses of Congress of a slightly amended version of “The Healthcare and Education Reconciliation Act” (HR 4872), the so-called “fixer bill” to the “Patient Protection and Affordable Care Act” (HR 3590), the healthcare reform legislation that was passed by the US House of Representatives on Sunday Mar. 21 and signed into law (Public Law No,111-148) by President Barack Obama on Tuesday Mar. 23. The reconciliation legislation (HR 4872) now goes to the President for his signature, which would clear the last hurdle for healthcare reform after a grueling week of intense debate and parliamentary efforts to both advance and stop final passage. The debate on the myriad of measures in the healthcare reform package will no doubt continue, but as the dust settles, at least momentarily, what are some of the implications for the pharmaceutical and biotechnology industries? Read more »

Gearing Up for Another Round in Healthcare Reform

Patricia Van Arnum PharmTech editor The US Senate’s vote this past weekend to proceed with debate on a legislative proposal for healthcare reform portends—what by all accounts—promises to be yet another rigorous round of policy and political opinion. A Google search for the past week alone shows that almost 500,000 blogs (459,049 at the time of posting of this blog) have been posted in response to the Senate’s action to move forward with considering healthcare reform. In the swirl of this public opinion, where does the pharmaceutical industry stand? Read more »

Strutting and Fretting about Healthcare Reform

Erik Greb PharmTech editorAfter much ado, the US House of Representatives passed a healthcare-reform bill this weekend. Drugmakers and commentators are understandably eager to parse the bill to find out what it would mean for the pharmaceutical and biopharmaceutical industries. So what’s the verdict? Read more »

PhRMA and BIO Weigh in on Healthcare Reform

Patricia Van Arnum PharmTech editor Following President Barak Obama’s address on healthcare reform to a joint session of Congress this week, the pharmaceutical and biotechnology industries reiterated their overall support for healthcare reform. Although not commenting in detail on specific measures offered by the President or Congressional proposals, the pharmaceutical and biotechnology industries will be important players in the upcoming weeks and months as the final proposals for healthcare reform materialize. Read more »

A Rx for Healthcare Reform

Patricia Van Arnum PharmTech editor As Congress prepares to reconvene next week, healthcare reform will be the number one item on the policy agenda. The White House announced this week that President Barack Obama will address a joint session of Congress, next Wednesday, Sept. 9. His speech, perhaps signaling more direct involvement by the President in proposals to revamp the country’s healthcare system, represents a critical juncture in the healthcare debate and yet-to-be determined implications for the pharmaceutical industry. Read more »

BIO–1, GPhA–0

Erik Greb PharmTech editorThe Biotechnology Industry Organization (BIO) has won the latest battle over follow-on biologics. Last week, the House Energy and Commerce Committee approved Rep. Anna Eshoo’s (D-CA) amendment to the America’s Affordable Health Choices Act (H.R. 3200). The Eshoo amendment, a regulatory pathway for the approval of biosimilars, would grant about 12 years of market exclusivity to each new biological medicine. Read more »

Chutes, Ladders, and Healthcare Reform

Erik Greb PharmTech editorCongress has taken up the Obama administration’s goal of making healthcare more affordable by introducing various strategies for reducing the cost of prescription drugs. But the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization (BIO) have resisted several of Congress’s initiatives, and cost control has been elusive so far. Read more »

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