Reform Rodeo

1. Useful Tools:  The Commonwealth Fund has released a nice tool that provides a timeline of ACA, as well as a means by which to filter the provisions based on a number of criteria.

2. Misinformation: Maggie Mahar describes some of the misinformation that is coming out of the state of Texas regarding health care reform.

3. Exchange Obstacle: Timothy Jost provides a fantastic overview of the obstacles that states and federal governments will face in the process of implementing the exchanges under the ACA.

4. Preventive Care: Somewhat out of character, the Los Angeles Times runs a piece about the irrationality that has surrounded the Preventive Services Task Force and evidence-based medicine in general.

5. Pharma Initiatives: The New England Journal of Medicine provides an overview of the policy initiatives and incentive programs that govern market exclusivity of pharmaceuticals.

The Biosimilars Debate: Is it Over?

An interesting cell formation observed in this group of cells treated with progesterone and stained with filipin, which is a natually fluorescent antibiotic that binds solely to free cholesterol. Viewed via a phase contrast microscope.

Two months ago, I discussed possible federal legislation intended to balance the competing need for scientific and medical innovation with the costs to patients for biosimilars.  So where does the debate stand now?

Current proposals couple a regulatory approval pathway for biosimilars with exclusivity periods for pioneer biologics.  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.   On July 31, despite protestations from Rep. chairman Henry A. Waxman (D-Calif.) that the amendment is “exactly the wrong way” to create a pathway for approval of biologics, the House Energy and Commerce Committee approved H.R. 3200, which also includes a 12-year exclusivity period.

On September 29, ten governors wrote a letter in support of the exclusivity period to House Speaker Nancy Pelosi (D-Calif.), House Minority Leader John Boehner (R-Ohio), Senate Majority Leader Harry Reid (D-Nev.), and Senate Minority Leader Mitch McConnell (R-Ky.), stating, “[i]nnovator companies must be provided with at least 12 years of non-patent data exclusivity to allow for recovery of their original investment and to ensure licensing payments to our research institutions.” Read more

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