LOS ANGELES — Gov. Jerry Brown has vetoed a bill that critics said would have hindered the use of cheaper versions of high-priced biotechnology drugs, providing a victory for health plans and generic drug companies over brand-name pharmaceutical manufacturers.
In a veto message on Saturday, Mr. Brown said the bill was premature because federal regulators had not even determined the standards governing the cheaper drugs.
Opponents of the bill had said it would make it harder for pharmacists to substitute cheaper copies for the brand-name versions of biotech drugs, some of which can cost tens or hundreds of thousands of dollars a year. Supporters said the bill was necessary to ensure patient safety.
With billions of dollars in sales at stake, biotechnology companies, led by Amgen and Genentech, have been lobbying in many states this year for laws like the one considered in California. But California has attracted particular scrutiny because of its size and because it is the home state of Amgen, Genentech and many other biotechnology companies.
Biotech drugs, known as biologics, include blockbusters with billions of dollars in sales each year like the rheumatoid arthritis treatments Enbrel and Humira and the cancer drugs Avastin and Herceptin.
Until now, biologics, which are complex proteins made in living cells, have been insulated from the generic competition eventually faced by simple chemical pills like Lipitor or Prozac. But the 2010 Affordable Care Act called for the F.D.A. to approve such copycat versions of biologics. They are usually called biosimilars rather than generics, because it is difficult to prove a copy of a biologic is exactly the same as the original.
Generic versions of pills are cheap partly because generic manufacturers do not have to market them. In most cases, pharmacists are allowed to substitute a generic for a brand-name drug.
The California bill, SB 598, would have allowed biosimilars to be substituted by pharmacists if the F.D.A. deemed the biosimilar "interchangeable" with the reference product, a higher standard than merely being similar.
But the bill, which passed both houses of the legislature by wide margins, would have required pharmacists to tell the patient's doctor whether a biosimilar or the brand-name drug was dispensed. The pharmacist would have also had to notify the patient if the substitution was made.
Opponents of the bill contended that once the F.D.A. had declared a biosimilar interchangeable with the original product, notification of doctors and patients was unnecessary and would only raise doubts about the safety of biosimilars and discourage their use, they said.
The California Public Employees' Retirement System, which provides health benefits to more than 1.3 million people, opposed the bill. "If Calpers is unable to realize the full savings from interchangeable biosimilar products, we may ultimately be forced to raise prescription drug co-payments or health insurance premiums," it said in a letter to the bill's sponsor, Jerry Hill, a Democratic state senator from San Mateo.
Supporters of the bill, which included some medical societies and patient advocacy groups, said it was essential for doctors to know which drug was used in case problems arose. Even slight changes in a biologic might, for instance, cause a patient to have an immune reaction to a drug.
Mr. Brown seemed torn on notification. "This requirement, which on its face looks reasonable, is for some reason highly controversial," he said in his veto message. "Doctors with whom I have spoken would welcome this information. Calpers and other large purchasers warn that the requirement itself would cast doubt on the safety and desirability of more cost-effective alternatives to biologics."
He added, however, that since the F.D.A. had not yet decided on the standards for interchangeability, a notification requirement was premature.
The F.D.A., while saying it had no position on state bills, has said it would be rigorous in ensuring that interchangeable drug posed no extra risks. "Efforts to undermine trust in these products are worrisome and represent a disservice to patients who could benefit from these lower cost treatments," it said in a statement.
According to the Generic Pharmaceutical Association, bills have been proposed and defeated in 10 other states this year, including Illinois and Texas.
North Dakota enacted a law in line similar to that proposed by the biotechnology companies. Oregon, Utah and Virginia enacted laws but with sunset provisions that might take effect before any interchangeable drugs are approved. Florida enacted a law that does not require physician notification. Bills are still pending in Massachusetts and Pennsylvania.
The bills would affect only a small percentage of biologic drugs that are dispensed through retail pharmacies, like Enbrel and Humira. Most biologic drugs, like the ones to treat cancer, are administered in doctors' offices or hospitals.
The battle is now shifting to whether biosimilars should have generic names different from that of the reference products.
Once again, biotechnology companies contend that this is necessary so that any safety problems that arise can be traced back to a particular manufacturer. The generic manufacturers say that if a biosimilar has a different name from the reference product, substitution by a pharmacist would not be allowed.
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