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In my mind, I still see my grandpa Gerrit as he was 10 years ago. I remember him as many see those old family movie reels: silent, skipping, and far too fast. He was my role model, teaching me to read with his funny character voices in our family room. I remember his "Kermit the Frog" smile and his sparkling eyes. He was patient. He loved. Now, it is my turn to show that same patience and love to him. My grandfather has Alzheimer's disease.
Recently, Wyeth's Bapineuzumab entered phase III trials. Bapineuzumab is one of the first drugs with the potential to treat the root causes of Alzheimer's disease - with the potential to help my grandfather enjoy a few more years with his family. Unfortunately, this "biologic" drug, like many cutting-edge treatments, will likely come with a steep price tag. Looking at recent history, a good example is the $48,000 a year Genentech-Roche charges for Herceptin, a common breast cancer chemotherapy.
Herceptin, a complex protein that prevents cancer cells from multiplying, is one of many hot new biologics - medicines derived from living cells. Biologics hold unprecedented potential as vaccines and therapies for diseases such as diabetes and cancer, but they cost on average 22 times as much as traditional drugs. Biologics are expected to account for 50 of the top 100 drugs by 2014.
As these expensive biologics become more common, healthcare costs are sure to rise. Meanwhile my grandparents, like half of America, live on an income of less than $50,000. Legislation in its current form provides no access for one of the most proven ways to lower drug prices: generic competition.
There is currently no FDA approval process for generic or "biosimilar" versions of biologics. These generic brands create competition which pushes down prices 20 to 40 percent and keeps drugs affordable. Generic drugs have saved Americans more than $700 billion in the past decade alone. Innovator companies deserve enough protection to make a return on their investment, but in the meantime patients like my grandfather need the affordable alternatives that generic competition can provide.
In recent weeks, two congressional committees finally passed proposals which claim to provide a route for biogeneric FDA approval. Sadly, both proposals fail to actually provide enhanced access to medicines. In fact, these proposals could prevent generic competition for biologic drugs for the foreseeable future.
The proposed framework more than doubles the number of years of exclusivity offered to brand-name biologics - 12 years - compared with five years' protection granted conventional drugs. During this monopoly period, it remains impossible for the generic industry to show the similarity of their follow-on biologic drugs which is required to gain approval to enter market.
Worse yet, the proposal contains ambiguous language that provides loopholes to allow pharmaceutical companies to renew this 12-year protection over and over by making small alterations to the brand-name product.
Drug companies claim they need increased protections for biologics because of higher research and development costs compared with conventional medicines. However, PhRMA's own 2006 Pharmaceutical Industry Profile contests that claim, demonstrating that R&D costs for biologics and conventional drugs are comparable. To justify its demand, industry points to the fact that biologics take seven months longer in clinical development than conventional drugs - but they ask for seven years of extra protection.
The U.S. Federal Trade Commission recommended zero years of exclusivity for these biologic drugs. Rep. Henry Waxman, D-Calif., and Charles Schumer, D-N.Y., have championed a compromise of five years - the same exclusivity awarded to traditional medications. Biogenerics already face a high threshold for imitation and numerous market barriers, and they have the potential to save billions of dollars and countless patients' lives. It is our responsibility to patients, families and friends to support no more than five years data exclusivity for these essential medicines.
