Politics and medicine: Pa. legislators are out of their depth on new drugs

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Several big health care issues are pending in Harrisburg -- the overhaul of Medicaid, the availability of health insurance for children and the battle between local giants UPMC and Highmark.

One idea, though, seems to be pure mischief and, if enacted, could raise medical costs, reduce competition and tamp down innovation -- all in service to big pharmaceutical companies.

House Bill 746 and Senate Bill 405 would regulate substances called "biosimilars." Unlike prescription drugs made of chemical compounds, biological medications -- used to treat cancer and lupus, for example -- are made from living material such as blood or protein. As such, it is much more complicated to produce less-expensive substances -- biosimilars -- that are analogous to generic drugs.

The U.S. Food and Drug Administration is empowered to license them as long as it deems them interchangeable with the original and not different in any "clinically meaningful way" on safety, purity or potency. But the bills would make a bigger distinction between biosimilars and their originals than is made between generic drugs and their brand-name equivalents.

Currently, if a doctor says it's OK, patients can be given generic drugs, with simply a notification on the label. But when it comes to using biosimilars, the legislation would require the patient to consent in writing to the substitution, the pharmacist to notify the prescribing physician within 72 hours of dispensing it and the prescriber to keep a written record of the substitution for five years.

The Generic Pharmaceutical Association says that's a ruse and that when patients learn their doctors must be specially notified, they'll become suspicious and leery of using the biosimilars, driving customers to the more costly name-brand medications. Manufacturers contend doctors must be notified of substitutions because biosimilars are not identical to the originals.

As with most things medical, there's big money involved. Across the nation, two pharmaceutical giants, Amgen and Genentech, contributed $650,000 to states' legislative races in 2012, at least partly to promote passage of notification laws. Five states already have them on the books, and California's legislature passed a measure that is awaiting the governor's signature.

The FDA hasn't approved any biosimilars yet, but the impetus for doing so will be cost savings. The call on what is safe and what isn't should be made by FDA experts. Once those scientists have made the determination, the same rules that govern dispensing generic drugs versus brand names should provide sufficient safeguards.

Legislators don't have any expertise that trumps that knowledge, no matter how many hearings they conduct.



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