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Federal drug safety law may limit access to bevacizumab
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CHICAGO – Recent federal drug safety legislation may affect patient access to bevacizumab, an expert said at a press briefing here.
“[It was important to us] because of the implications that it has for access to pharmaceuticals, physician-administered pharmaceuticals in particular, and whether or not bevacizumab (Avastin, Genentech) can stay in the marketplace as an off-label ophthalmic product,” Michael X. Repka, MD, American Academy of Ophthalmology medical director for governmental affairs, said.
Michael X. Repka
The Drug Quality and Security Act, passed by Congress and signed into law in 2013, gives the U.S. Food and Drug Administration discretion in deciding how repackaged products and drugs produced by traditional compounding pharmacies for office use may be handled.
The FDA has not published guidance on access to compounded products for office use or repackaged products such as bevacizumab, according to an AAO document.
“The key was that [the FDA] has decided that even if state law allowed for a drug to be produced by a compounding pharmacy, the prescription has to be patient-specific,” Repka said. “That creates, in a routine situation where you’re giving a drug frequently, a bit of difficulty because you don’t want to order if the patient doesn’t show up. On the other hand, you don’t want to order after they show up because then they have to come back. So, it’s not a particularly patient-friendly interpretation in terms of that.”
Regulations on outsourcing pharmacies have not been finalized, Repka said.
Disclosures: Repka has no relevant financial disclosures.