HB 365, which was approved by the House Health Quality Subcommittee, would set guidelines for the dispensing of substitutes in Florida. Among other things, it would require pharmacists to notify prescribing doctors within five days and keep records for at least four years of making the substitutions.
Sponsor Matt Hudson, R-Naples, said such requirements would help protect patients, as the types of drugs are more complex than chemical compounds. He said biologic drugs are used to treat various types of cancers, along with ailments such as rheumatoid arthritis.
"They are used for some very difficult conditions of the humankind,'' Hudson said.
But major players in the pharmaceutical industry are divided on the bill. While it is supported by the Pharmaceutical Research and Manufacturers of America, it faced opposition Tuesday from pharmacy-benefits manager Express Scripts and the drug company Novartis.
At least part of the opposition stems from arguments that the requirements in the bill could place barriers to pharmacists dispensing the substitutes -- an argument Hudson rejects. The opponents also said the state should not approve the bill before the federal Food and Drug Administration provides guidance about the drugs.
While the substitutes are used in places such as Europe, they still need FDA approval. The federal agency has to determine whether substitutes are "biosimilar" to the original drugs and can be interchangeable.
"Let's let the expertise of the FDA govern this area,'' said David Dederichs, a lobbyist for Express Scripts.
The New York Times reported last month that similar battles are taking place in several state capitals. It reported that drug companies Amgen and Genentech, which make top-selling drugs for treating cancer and other diseases, are supporting the bills. Representatives of those companies did not speak at Tuesday's subcommittee meeting.
Hudson and other speakers said the market for biologic drugs remains relatively small, but it was apparent from the turnout of lobbyists that the issue has high stakes for drug companies. The subcommittee voted 10-1 to approve the bill, which has been assigned to two other House panels. Sen. Denise Grimsley, R-Sebring, has filed a similar measure (SB 732) in the Senate.
While the House panel overwhelmingly approved the proposal, some members expressed concerns about it.
"I feel we're trying to write laws without knowing what the feds are going to do yet,'' said Rep. Eddy Gonzalez, R-Hialeah.
Major physician groups, including the Florida Medical Association and the Florida Osteopathic Medical Association, backed the proposal. They pointed to the bill's requirement that pharmacists would have to notify doctors if patients receive biologic drugs.
"Notification is a very important aspect of this,'' said Stephen Winn, executive director of the Florida Osteopathic Medical Association. "A physician should be notified when a substitution occurs."
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