Florida legislature passes biosimilar substitution bill
NEW YORK — Florida’s state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.
The bill, which was approved last Tuesday and is scheduled to take effect on July 1, institutes requirements for pharmacists to substitute biosimilars when they are determined to be biosimilar to and interchangeable with the brand name product, while also requiring the state board of pharmacy to maintain a current list of interchangeable products.
The bill is the latest episode in an ongoing battle between the generic drug industry and biotech companies. Several states have considered legislation that would allow physicians to side-step pharmacists who would otherwise substitute a biosimilar drug while requiring the pharmacist to notify the physician and patient when substitution had taken place; Virginia Gov. Bob McDonnell signed such a bill into law earlier this year, but it contained a sunset provision, meaning that it would expire after two years.
The Patient Protection and Affordable Care Act of 2010 included an amendment creating an abbreviated regulatory approval pathway for biosimilars, but the Food and Drug Administration still has to create regulations for them before it can approve biosimilars under such a pathway; for the time being, some drug makers such as Teva Pharmaceutical Industries have sought approval for biosimilars under the pathway used for brand-name biotech drugs.
The generics industry sees such bills as an attempt to limit access to biosimilars, touted as cheaper alternatives to brand name biotech drugs, which can cost tens of thousands or even hundreds of thousands of dollars per year. Meanwhile, biotech companies say that because of the unique properties of biotech drugs, it is difficult or impossible to create an exact replica of one, as is the case with generic pharmaceutical drugs. As such, they say, there is a risk that biosimilars may differ from their brand-name counterparts in terms of safety and efficacy, a claim that generic drug companies reject.
The Generic Pharmaceutical Association, a trade group for the generic drug industry, heralded the Florida bill’s passage.
"Florida spent more than $104 million on biologic medicines in 2011 alone for its state Medicaid program, a number that only will grow," GPhA president and CEO Ralph Neas said. "Once the FDA approves full guidance on biosimilar approval and interchangeability, we are confident that states like Florida will benefit enormously fro these lower-cost, life-saving medicines."
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CVS handles back-end functions as Pfizer sells Viagra online
NEW YORK — Pfizer is attempting to stem the rise of counterfeit medicines by selling one of its most popular drugs — and one of the most popular targets for counterfeiters — online.
The drug maker announced that it had launched Viagra (sildenafil citrate) home delivery, a prescription-fulfillment website for the drug, which is powered by CVS/pharmacy and accessible through Viagra.com.
"Through our ongoing analyses, we’ve seen how fake pharmacy websites can lure consumers into buying counterfeit medicines with what seems to be an easy purchase experience, but it may be putting their health at risk," National Association of Boards of Pharmacy executive director Carmen Catizone said. "We’re pleased to see companies collaborating to develop and support solutions that will help patients obtain legitimate prescription medications online."
With the website, men with prescriptions for Viagra can submit it through the website, while CVS will handle the back-end functions, including authentication.
Pfizer noted that there are almost 24 million searches for Viagra online every year, but a review by the NABP of more than 10,000 online pharmacies found that 97% of them were illegitimate. In response, the organization and government agencies have sought means of stemming the spread of the illegal pharmacies. Last month, the Food and Drug Administration launched BeSafeRx, an interactive online map that helps users distinguish legitimate online pharmacies from fake ones, while the NABP has proposed a ".pharmacy" top-level domain reserved for the websites of licensed online pharmacies. The FDA, NABP and others have warned that consumers who purchase drugs from illegitimate online pharmacies may be putting themselves at risk of using drugs that are contaminated, counterfeit, adulterated or expired.
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Pregnant women shouldn’t use valproate drugs to prevent migraines, FDA warns
SILVER SPRING, Md. — Pregnant women should not use migraine-prevention medications containing valproate sodium due to a higher risk of decreased IQ scores in children, the Food and Drug Administration warned Monday.
In addition to being used to prevent migraines, valproate drugs are used for treating epilepsy and bipolar disorder and include related drugs such as divalproex sodium and valproic acid. Most are available in generic form as well as under brand names like AbbVie’s Depacon and Depakote and others.
Drugs containing the drug already have a boxed warning — the strongest FDA-mandated warning on a drug label — for risks to unborn fetuses, including birth defects, but the latest warning is based on a recent study tying use of the drugs to lower IQ scores in children, the FDA said.