URGENT VOTE IN HOUSE ON FRIDAY: Help Control Drug Costs by Contacting Your Representative TODAY

URGENT VOTE IN HOUSE ON FRIDAY: Help Control Drug Costs by Contacting Your Representative TODAY

As early as TOMORROW (Friday July 17), the House Energy and Commerce Committee will vote on how much additional monopoly protection to give to biologic drugs -- those engineered from living cells such as cancer treatments and vaccines -- as part of the health care reform package. Specifically, they are voting on a proposal authored by Representatives Eshoo and Barton that would grant biologic drugs an unprecedented total of 14.5 years of data exclusivity, a monopoly period that would delay the introduction of price-lowering generic competition for crucial life-saving treatments for illnesses like cancer, arthritis and diabetes as well as vaccines. The 14.5 year time period is almost three times as much as what is given to brand-name traditional chemical drugs, and will keep affordable generic biologic medicines out of the hands of consumers in the U.S. and in developing countries for far too long.

The Senate had their turn earlier this week, now it’s crucial we turn our attention to the House of Representatives!

What can you do?
Representatives Anna Eshoo (D-CA) and Joe Barton (R-TX) are seeking to add their 14.5 year biogenerics proposal (originally H.R. 1548) to the House health care reform bill by amendment as early as tomorrow. They have strong support but there are enough representatives on the fence that we can turn the situation around and have the amendment defeated so that a better proposal can be adopted. A much better proposal is from Representative Waxman and Senator Schumer (H.R. 1427/S. 726) which calls for 5 years of exclusivity.

We need your help to change this. Will you call and/or email the key swing representatives on the Energy & Commerce Committee today and ask them to vote NO on the Eshoo-Barton biologics proposal? Tell them that 14.5 years data exclusivity for biologics is too much and that nothing more than a seven (7) year compromise should be accepted. [Scroll to the bottom for contact information and a script]

The Obama Administration recently indicated that a base period of seven years data exclusivity is a “generous compromise” between the zero (0) years recommended in a recent Federal Trade Commission Report and the 14 years being sought by the brand name pharmaceutical and biotech industry (PhRMA and BIO). This 14.5 year data exclusivity period in the Eshoo-Barton proposal is about twice the length of time proposed by the White House and almost three times the base period of five (5) years given to traditional chemical drugs under the 1984 Hatch-Waxman Act. The brand-name pharmaceutical and biotech industry, supported by the American Association of Universities, has been aggressively lobbying Congress for an FDA approval pathway for generic biologics (also called biosimilars, biogenerics or follow-on biologics) that gives them a minimum of 14 years of data exclusivity.

What is data exclusivity? When a generic company seeks approval for a generic drug, it shows that its product is the same as, or essentially similar to, a brand-name product. It then relies on, but does not repeat, the full battery clinical tests performed by the brand-name maker. Data exclusivity prohibits the generic firm from relying on the brand-name test data, effectively barring the generic from the market for a set period of time. It gives the brand-name firm a monopoly on selling that product, a monopoly separate and distinct from the patent monopolies already attached to these products, and which will not be disturbed by the legislation (meaning drug makers will still have their patents to rely on to earn mega-profits).

Why is data exclusivity a danger?
Data exclusivity can delay the introduction of price-lowering generic drug competition -- keeping prices high longer -- for drugs that are not able to obtain patent protection, or for which the patent term has already expired. Several studies, including a recent Federal Trade Commission report [i],found that 14 years of data exclusivity is NOT necessary for PhRMA and BIO to make huge profits.

Important biologics include several of the most important drugs used during chemotherapy, for the treatment of severe arthritis and psoriasis and very importantly, vaccines. Biologic drugs are the fastest growing segment of the pharmaceutical market, and they are priced significantly higher on average than brand-name conventional drugs. In some cases, prices approach or exceed $100,000 per patient, per year. Biologics priced at tens of thousands of dollars per patient per year are commonplace. For example, the top-selling biologic Enbrel, Pfizer/Amgen's arthritis treatment, costs $15-20,000 per patient per year. Roche-Genentech's breast cancer drug Avastin costs approximately $185,00 per year.

What can you do?
As early as this Friday, Representatives Anna Eshoo (D-CA) and Joe Barton (R-TX) are seeking to add their 14.5 year biogenerics proposal to the House health care reform bill by amendment. They have strong support but there are enough representatives on the fence that we can turn the situation around and have the amendment defeated so that a better proposal can be adopted.

We need your help to change this. Will you call and/or email the key swing representatives on the Energy & Commerce Committee TODAY and ask them to vote NO on the Eshoo-Barton biologics proposal? Tell them that 14.5 years data exclusivity for biologics is too much and that nothing more than a seven (7) year compromise should be accepted. [Scroll to the bottom for contact information and a script]

It is extremely urgent to call as soon as possible as Congress is unpredictable. The decision could be finalized as early as FRIDAY JULY 17! Please call or email as many of the representatives as possible (calls are best but email is good if you can’t call or don’t reach the staff by phone). It is best if you live or have lived in their districts, but it is NOT essential. You can simply tell them you are a representative of the many student members of UAEM or the American Medical Student Association (as appropriate) if you are not from their districts.