US Healthcare Reform Reflects Changing Life Sciences Industry
After decades of debate,
Included in ACA is a long-anticipated approval pathway for ‘biosimilars’, or drugs that are shown to be clinically similar to, or potentially interchangeable with, brand name biologics. Congress created statutory authority for the FDA to accept and approve marketing applications for new biologics that would compete with established innovator biologics following expiration of the innovator’s patents. The legislation ensures 12 years of marketing exclusivity and other patent protections for the innovator, an important win for the biotech community. With the pathway in place, the FDA must now establish guidance and criteria to measure ‘similarity’ and ‘interchangeability’. The FDA is currently conducting hearings with biologics manufacturers, generics companies, physicians and others to solicit input on implementation methodology while ensuring patient safety and efficacy. A marketing approval pathway for biosimilars already exists in Europe, where the EMEA began approving biosimilar products in 2006, and the
Comparative effectiveness research has been one of the most-discussed topics among pharma and device manufacturers over the last few years, and ACA brought CER another step closer. The Act included provisions, and funding, for a private, non-profit Patient-Centered Outcomes Research Institute to set national priorities for researching and comparing post-approval efficacy of medical treatments. The goal of the research will be to analyse and interpret ‘real-world’ treatment outcomes utilising the vast amounts of data available today from multiple sources including payer databases, online patient communities and electronic health records, as well as the FDA’s 2008 Sentinel Initiative to electronically track the safety of marketed drugs and devices. Manufacturers accept that they must prepare for and adapt to an environment in which comparative effectiveness data will be publicly available and relied upon by physicians, patients, regulators and payers to identify the most effective treatments for specific patient populations.
Access to capital during the recession for the development of promising new technologies remains a challenge for small biotech and device companies. To promote continued research and development, Congress included in ACA a provision for $1bn of new grants and federal tax credits for qualifying research and development projects that seek innovative therapies to prevent, diagnose and treat acute and chronic diseases. In November 2010, the Internal Revenue Service and the Department of Health and Human Services announced 4606 awards to 2923 small companies in 47 states, covering R&D investments made in 2009 and 2010. Under the final allocations, the maximum award for a single project was approximately $244,000 with some applicants receiving awards for multiple projects.
Outside ACA, litigation currently making its way through the federal courts could also have far-reaching consequences for the biotech industry in the genomics field. In March 2010, a
Overall, growth in the
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