Weekend update

The Senate is in session at the Capitol this week while the House has a district work session according to the Hill’s Floor Watch blog. OMB Director Sylvia Burwell’s nomination to serve as HHS Secretary will be taken up later this coming week.

The Hill also has an article about the Sovaldi pricing battle. The article notes that the health insurance trade association’s (AHIP) spokesperson, Robert Zirkelbach, has moved over to be the spokesperson for the prescription drug trade association, PhRMA.  AHIP has hired Brendan Buck, a former spokesperson for the House Speaker, to be its new spokesperson.

In a bit of good news, the New York Times reports that the Food and Drug Administration on Friday approved a generic version of the anti-inflammatory painkiller Celebrex. “Teva [Pharmaceuticals now] has exclusive marketing rights to three doses of the drug for 180 days. Mylan received approval for the lowest dose of the drug, 50 milligrams. Celebrex was Pfizer’s fourth-best-selling drug last year with sales of $2.92 billion.” According to the Times article, generic drugs are priced 30% to 60%  lower than the brand name drugs. It has been over four years since Congress in the Affordable Care Act authorized the FDA to create a regulatory pathway for generic versions of specialty drugs known as biogenerics or biosimilars. Fierce Biotech reports that in mid May, the FDA broke its silence on the issue with nonbinding draft guidance on such a regulatory pathway. The article notes that “the industry is hardly standing pat. In the four years since Congress authorized the agency to sort out an approval pathway for biologic copies, many makers of proprietary drugs have started investing in their own biosimilar operations, including Amgen, Merck, and Biogen Idec.”  The European Union started approving biosimilars early in the last decade.

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