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 »

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 »

GSK is doing good deeds again. The Big Pharma company recently signed an agreement with the Global Alliance for Vaccines and Immunization (GAVI, Geneva) to provide children in Africa with its pneumococcal vaccine, Synflorix. Read more »

I get a lot of email on a normal day, but yesterday the day after the House passed “The Patient Protection and Affordable Care Act of 2009,” my email box was full of opinions and reactions. Barack Obama himself wrote me to say “thank you.” Because of me, it appears “every American will finally be guaranteed high quality, affordable health care coverage.” Read more »

I’ve written previously about the potential health dangers that discarded drugs pose to our water supply. This year, 13 states are considering bills that would create drug take-back programs. Maine’s House of Representatives recently endorsed a plan that would require drug manufacturers to set up and operate programs to collect, transport, manage, and dispose of unwanted drugs. Read more »

Legislators and regulators on both sides of the Atlantic have spent the past decade trying to improve access to safe and effective pediatric formulations and drug products—but it’s unclear whether pharma companies are taking notice. Read more »

This afternoon, FDA Commissioner is expected to help launch the Critical Path to TB Drug Regimens (CPTR)—an initiative aimed at accelerating the development and approval of new treatments for tuberculosis (TB). Supporting the initiative are the TB Alliance, the Bill & Melinda Gates Foundation, the Critical Path Institute (C-Path), and 10 pharmaceutical companies: Johnson & Johnson, sanofi-aventis, Pfizer, AstraZeneca, GlaxoSmithKline, Bayer, Otsuka, Novartis, Sequella and Anacor Pharmaceuticals.
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The European debate about combating counterfeit medicines is generating a lot of heat in Brussels as it comes to a head. In March the European Parliament is starting to tackle the detail of the European Commission’s proposal to stop falsified products getting into the legal supply chain – about the same time as officials from the EU member countries are nearing some sort of view on the technicalities. Read more »

Sourcing, procurement, and supply-chain professionals from the pharmaceutical industry and their suppliers are gathering this week in New York City at DCAT Week, an annual event of educational programs and business-networking opportunities organized by the Drug, Chemical and Associated Technologies Association. (DCAT). The first day of the event kicked off on Monday with an educational program addressing the impact of changing market fundamentals on innovator-drug and generic-drug companies. Read more »

This morning I read about a public–private collaboration that reflects many of the latest trends in the drug industry today. The project began when the University of Pittsburgh Medical Center (UPMC) created the 21st Century Biodefense (21CB) initiative to enhance the nation’s biosecurity. Robert J. Cindrich, who is leading the initiative, said in a press release that the project’s goal was to foster advances in vaccine development and manufacturing. Battelle (Columbus, OH), a research and development organization, IBM (Armonk, NY), Merck (Whitehouse Station, NJ), and GE Healthcare (Waukesha, WI) have all joined the collaboration so far. Read more »