Drug bill receives boost in House
02/20/2013
The measure, HB 365, deals with a growing market for what are known as "biologic" drugs that are developed by using living cells instead of making chemical compounds. The debate centers on patients who receive substitutes for the original version of the drugs, an issue somewhat akin to the longstanding practice of substituting cheaper generic drugs for name-brand chemical drugs.
The measure, 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.
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.
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