DC WIRE

NO SHORTCUTS TO PATIENT SAFETY
By Robert Goldberg, PhD

Listening to President Obama assure Americans that two-thirds of the money for the government take of health is already paid for, you wouldn’t know that $70 billion comes from a shortcut for pushing “generic” forms of biotech products onto the market with requiring those copying the products to submit their versions to the FDA for testing.
Unknown Side Effects
As those who read this publication know, biological products—even those manufactured exactly as the original—have distinct differences, so their side effects are often unknown until they are on the market. As such, these copies can result in vastly different degrees of safety and success in patients. Even new biologics have that risk, which is why the FDA requires all new medicines to have a risk management plan that at the very least involves monitoring potential side effects after a product is marketed.
But the Obama Administration is obsessed with finding every single dime to pay for its version of healthcare reform. And it can only “score” savings by skipping over safety requirements for biosimilars, a shortcut reliably provided for by Congressman Henry Waxman’s version of healthcare reform legislation. Which is pretty ironic, since in September 2006, the Congressman criticized the FDA for approving new uses of antibiotics already on the market by testing them against other drugs instead of placebos, noting: “Permitting drug companies to take shortcuts in their clinical trials poses real risks.” In fact, Waxman’s recent legislation and letter to the President allow biosimilars to go to market without any human testing and would allow copycats to take over the name of the original product even if the FDA doesn’t determine they are exactly alike.
Supporters of biosimilars often use European approvals as an example of how safe it is to save money with biosimilars. The European pathway is exactly what Waxman sidesteps. A Frost & Sullivan report noted of the European approval process that “clinical trials . . . are required to compare quality, safety, efficacy . . . data between the biosimilar and the reference product, in addition to a pharmacovigilance trial. Supplementary trials may be required depending on the complexity and formulation of the product. Omnitrope [a version of Genetech’s human growth hormone], for example, required a phenomenal 18,000 syringes of Genotropin [Genetech’s product] to be imported every week during the clinical trial process.”

No Existing Pathway
Finally, it’s wrong to tell the President that the FDA has existing pathways to approve generic biologics. Last year, the FDA told Genzyme it would not only need approval for a larger new manufacturing plant to produce Myozyme, a biologic for Pompe disease, it would need a new drug approval! The FDA maintained that because the manufacturing process was different by virtue of a single change in one molecule from the smaller facility producing Myozyme that the drug itself be called Lumizyme.
Clearly a pathway needs to be created. The way to do so is by encouraging companies to share data and work with the FDA to develop standards about making and prescribing biologics of all types that everyone can safely use. In fact, Congresswoman Anna Eshoo’s Pathway to Biosimilar Approvals Bill provides innovators with incentives (called data exclusivity) to develop information about the impact a product and its manufacturing processes will have on patients. That’s safety information the Waxman bill neither requires or recommends. The Eshoo bill has three times as many co-sponsors as the Waxman proposal attached to his healthcare bill.
In the end, it’s not about safety. It’s about shortcuts to save money.

Robert Goldberg is co-founder and vice president of the Center for Medicine in the Public Interest (cmpi.org), a nonpartisan research and educational organization focused on patient-centered healthcare. He blogs at www.drugwonks.com and welcomes comments there.

The views of the author are his own and are not necessarily those of the publishers of PM360.

Robert Goldberg is co-founder and vice president of the Center for Medicine in the Public Interest (cmpi.org), a nonpartisan research and educational organization focused on patient-centered healthcare. He blogs at www.drugwonks.com and welcomes comments there.

The views of the author are his own and are not necessarily those of the publishers of PM360.