The House Democrats’ Health Care Plan Unveiled, Questions on Women’s Access to Health Care Remain

Last Thursday, October 29^th, House Democrats announced their bill for health care reform, the Affordable Health Care for America Act.  The House bill includes provisions such as a public option and employer mandates.  For women, the House bill has been a controversial issue; though the bill contains provisions that will expand women’s access to certain areas of health care, other areas have been neglected.

On the plus side is the bill’s prohibition of domestic violence being categorized as a pre-existing condition for health insurance purposes.  Ms. Pelosi was able to follow through on her promise to women that such a discriminative practice would be ended through the House bill.  Meanwhile, U.S. News attributes the inclusion of women’s health needs in the bill to the widespread women-led activism for health care reform.  Still, as significant aspects of women’s access to health are yet left unaddressed, some advocates wonder if we should have asked for more.

One issue of contention is that an amendment to the the bill allows for 12 years of exlcusivity for biologic drugs– some of which have been found particularly efficacious in the treatment of breast cancer. In addition to the 12 year exculsivity period, manufacturers will also be able still to engage in the process known as “evergreening,” the practice of changing a drug slightly–such as altering the time release mechanism– and thereby garnering additional periods of exclusivity. These periods of exclusivity prohibit cheaper generic versions of the drug– known as “follow-on biologics” or “biosimilars” from entering the marketplace. (To read more about the biologic exclusivity debate read here and here.) The end result would seem to point– if money matters (and when does it not?),  to a decrease in the availability of breast cancer biosimilars and thus a decrease in available efficacious treatment.  One of the bill’s sponsors, Anna Eschew of California, defends the proposal on the grounds that it does not interfere with women’s access to breast cancer treatment, and that it only curbs the ability of bio-pharmaceutical generic competitors to freely utilize the costly, extensive research and development of the original bio-pharmaceutical innovators.  Eschew believes that lesser periods of exclusivity will have a chilling effect on biologic research and development– as lesser exclusivity would make it more difficult for the original developers of the drugs to recoup the large expenses associated with such development.

Reproductive health care issues have also come to the forefront of the debate, but with a clear consensus yet to have emerged on what the bill does or does not cover within the various exchanges, options and subsidies within the bill.

While political groups are preparing to battle out these issues, one thing remains constant, women are a force that both democrats and republicans want on their side.  The House Democrats were paying attention when drafting their health plan, but the holes still left in women’s health care access might mean that women need to make themselves heard again–and this time, maybe a little louder.

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