Mintz Levin: “Health Care Reform Advisory: Assessing the Impact of Federal Health Care Reform on Employers and Employer-Sponsored Group Health Plans”

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I’ve written before on this blog about the value of Mintz Levin’s reports, and am about to do so again (you can find their  work, as a permanent link, under “Resources” on this blog). There is, linked below, a very nicely done recap of the health reform law– which gets quickly to the point regarding the implications of a number of provisions within the law for employers and employer-sponsored group health plans. For those of you unfamiliar, Mintz Levin is  a law firm with its primary office in D.C., and a health sciences group with a well deserved reputation for excellence. If you are an employer, or even an employee that has some appropriate notion of “trickle-down,” I highly recommend you take a look.

Written by Alden J. Bianchi and Patricia A. Moran, “Assessing the Impact of Federal Health Care Reform on Employers and Employer-Sponsored Group Health Plans,” may be found here.

Biologics, How Long Exclusive? What Cost?

Expression of Fabp7 protein in mouse brains at embryonic day 16 (left) and postnatal day 0 (right). At both stages, Fabp7 is strongly expressed in the ventricular zone and radial glia, where neurogenesis is prominent. From, A Candidate Gene for a Biological Marker of Schizophrenia in Mice Gross L PLoS Biology Vol. 5, No. 11.

Biologics — products such as vaccines, gene therapy, tissues, and recombinant therapeutic proteins that are isolated from natural sources and may be produced by biotechnology methods and other technologies — are at the center of a national debate regarding access to cutting-edge therapies and protection of biotech’s ability to create products that may require millions of dollars to develop. As always, Mintz Levin, Health Law Washington Beat (link also in the “Resources” section of this blog) has offered great coverage of the issue– articles here and here.

For months now, the federal government has been considering legislation to balance the competing need for scientific and medical innovation with the costs to patients for biosimilars (generic versions of innovator pioneer biologics, also referred to as follow-on biologics).  Unlike its approval pathway for generic small-molecule, chemically synthesized drugs, the FDA currently has no process for the approval of biosimilars.  All regulatory proposals by both the Senate and the House have included an exclusivity period for pioneer biologics before a generic biologic may be introduced in the market, as well as patent protections for the pioneer biologic.

As part of its July 15, 2009 health reform bill, the Senate Health, Education, Labor, and Pensions (HELP) Committee adopted an amendment proposed by Senators Kay Hagan (D-NC), Michael Enzi (R-WY), and Orrin Hatch (R-UT) that provides for a 12-year exclusivity period for pioneer biologics.  Among the Senate’s other biosimilar proposals, all introduced in June 2009, Senator Sherrod Brown (D-OH)’s bill allows for seven years of exclusivity, Senator Charles Schumer (D-NY)’s bill provides for a 5 year exclusivity period, and the proposal by Senator Edward Kennedy (D-MA) calls for a nine-year exclusivity period.  In the House, Reps. Henry A. Waxman (D-CA)’s proposed bill limits the exclusion period to five years, while Anna Eshoo (D-CA)’s bill proposes an initial exclusivity period of 12 years, with a possible additional two-and-a-half years for new indications and pediatric populations.

In June 2009, the FTC released a report that determined that innovation and investment will be sustained even without the exclusivity recommended by even the least restrictive of the proposed bills.  The report states that the competition between pioneer and follow-on biologics will more closely resemble the competition between different brands of drugs — with the pioneer biologic retaining 70-90% of the market share — rather than the competition between small-molecule branded pharmaceuticals and their comparable generics — where entry of the generic drug on the market leads to loss of market share and drop in the price of the drug.  The FTC found that due to the complexities in the development and use of biologics and the absence of therapeutic equivalence between pioneer and follow–on biologics, biosimilars are unlikely to be direct substitutes for the pioneer biologics on which they were based.

Relying on the FTC’s conclusion that the introduction of follow-on biologics will lower prices and increase access, Read more

Mintz Levin: False Claims Act Amendments Gain Traction

William Hogarth, Satire on False Perspective (1753)

I’ve never done this before (except perhaps to introduce Ezra Klein’s new site), but I came across a really good Health Law feed on Twitter from Mintz Levin Health Sciences Practice. Good enough that you can now find it in the “Resources” section of this Blog. I was particularly taken by the report on the progress of the amendments to the Fair Claims Act in Congress. We have written at length about the Fair Claims Act and its use as an enforcement mechanism, but I was impressed by how clearly and cogently Mintz Levin described the current status of the efforts to amend as well as the implications– in a very short space. This link is to their feed, and  this one is to their Health Law Washington Beat: Recent Health Industry News - Issue 9. Click on Issue 9 and scroll down a little until you get to “False Claims Act Amendments Gain Traction in Both the House and Senate.”