Beyond the no-brainer concept that if necessary medicines are to be of any value to humankind, they must be affordable, the phrase “Affordable Medicines Now” has a special meaning in the struggle to achieve meaningful healthcare reform in the USA. The term is the name of an advocacy campaign to promote establishment of a rational pathway in the FDA for the approval of generic biologic medicines, known as “biosimilars.” Affordable Medicines Now is a collaborative effort of Universities Allied for Essential Medicines (UAEM), the American Medical Student Association (AMSA), Essential Action, and Knowledge Ecology International (KEI). I was invited to get involved with the campaign late last summer, when thing were really heating up with health care reform work in Congress.
The back story is that ,unlike for conventional medicines, there is currently no mechanism, or pathway, for the FDA to approve generic versions of biologic drugs. Biologics are different as they are made from living protein cells, while ordinary drugs are derived from natural and synthetic chemicals and compounds thereof. Currently, 43% of the Medicare Part B (outpatient care) budget goes to pay for biologics, whose major current uses are for diseases like cancers, rheumatoid arthritis, kidney disease, multiple sclerosis, and various immune disorders, metabolic diseases, etc. It is estimated given current usage, by 2014, half of all new drugs will be biologics, whose costs now run from tens to hundreds of thousands of dollars each year , greatly burdening patients and healthcare systems.In 2007, US sales of biologics amounted to some $75 billion.
In order to create the FDA pathway for approval of biosimilar drugs, Congressional authorization is needed. In July 2009, without much public awareness of what was going on, industry-backed versions of House and Senate bills were passed by the the respective committees considering them and were incorporated into healthcare reform packages . Even the strongest of progressive healthcare reform supporters like the late-Senator Ted Kennedy, then Chair of the Senate HELP Committee, and my own Senator Patty Murray of that committee, supported the industry position, stark evidence of the power of lobbying. These measures would mandate a minimum 12-year period of marketing exclusivity for biologic drugs, claiming that the lengthy time period is necessary for the biopharmas to recoup R& D costs. However, PhRMA’s own research has found that the R&D time period for both conventional and biologic drugs is essentially the same.
With the biopharma industry spending spending $1.2 million on lobbying every day that Congress has been in session, alternative biosimilar pathway legislation proposed by Senator Schumer and Congressman Waxman, for a 5-year marketing exclusivity period, has face a seemingly-insurmountable uphill battle. This has been despite the fact that a June 2009 Federal Trade Commission report Emerging Health Care Issues: Follow-on Biologic Drug Competition, recommended that there was no need for a period of marketing exclusivity at all. President Obama has repeatedly opined a that a 7-year period of exclusivity was more than sufficient to drive innovation and ensure that breakthrough drugs become affordable.
The take-home message from this situation is that as the critical work continues to get us decent healthcare reform , it is more urgent than ever to speak up loudly to make sure that any biosimilars legislation will truly benefit patients , not line industry pockets. The delay in finalizing the reform bill gives us a new opportunity to take action to remedy this bad provision. Indeed, Obama stressed again last month that he has not forgotten about this issue. Ideally, many advocates believe that it would make the most sense for the biosimilars pathway to be completely taken out of the healthcare reform bill, as it is not itself a health insurance reform measure. Biologics are such a major and growing, expense that the pathway deserves to be considered and debated on its own merits. Some of us speculate that the lobbying effort to incorporate it into the larger healthcare reform bill was a tactic designed to ensure passage with little scrutiny, as public and media attention focused on the most contested parts of reform.
The current situation also brings up another issue: why are the voices of concerned patients and disease groups not being heard on the life-and-death issue? Or why are the few groups who are speaking out, urging support for the industry-backed position via venues like PhRMA’s cleverly-named We Work for Health national and state campaigns ? The rather awkward question of “why haven’t we been hearing from patients?” is one that I have been asked each and every time I contacted and/or visited the local and DC offices of any of Washington State’s members of Congress, in the past 6 months or so. The reason seems to be a lack of awareness of what is going on, and the sad fact that many, if not most, patient and disease groups today receive some or much of their funding from the pharmaceutical industry. It seems to be a don’t-bite- the -hand- that -feeds- you phenomenon, about which Senator Grassley of Iowa has recently raised the alarm. The co-option of patient and health groups worldwide is a deep concern of mine, and one about which I will be writing much more in the future.
So it has never been more important for the perspectives of those directly affected by the astronomical and ever-skyrocketing prices of medicines to speak up. You can help spread the word by sending this information to everyone you know. We can’t sit back and wait for the day that disease organizations become genuine advocacy groups. There is great strength in voices of many individuals, which is why all of our Congresspeople must hear directly from us about the need for affordable medicines now, and how creating a just biosimilars pathway is part of the solution.
The Affordable Medicines Now campaign sent its reminder to Congress in the form of an e-Valentine, and has created an easy, online way for constituents to contact their members of Congress . While February 14th is past, your message is needed now!
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