In 2013, in the wake of infectious outbreaks traced to steroids and repackaged intravitreal Avastin produced at compounding pharmacies, Congress passed the Drug Quality and Security Act, which included the Compounding Quality Act. The law gives the FDA new authorities to regulate the activities of compounding pharmacies, drug repackagers and a new class of “outsourcing manufacturers.”
In subsequent guidance documents, the FDA clarified various requirements regarding the activities of traditional compounders, such as the need to receive a patient-specific prescription for each compounded drug. In a set of draft guidance documents issued in February, the FDA made recommendations on outsourcing facilities, mixing and repackaging, and interstate shipping. Some experts see some of the recommendations as a plus, while others have a less optimistic view.
Overall, the drug compounding law involves a “mixed bag” of upsides and downsides, according to Daniel A. Kracov, JD, OSN Regulatory/Legislative Board Member.
“At a high level, what I think ophthalmologists are going to see is somewhat less availability of certain products that they may have received from compounding facilities previously,” Kracov said. “The purpose of the act, in many respects, is to try to diminish the unlawful practice of compounding of large quantities of, particularly, injectable products in compounding pharmacies and to try to drive those activities into outsourcing facilities, which are subject to good manufacturing practices.”
Judy E. Kim, MD, OSN Retina/Vitreous Board Member, said that while she understands the need for improved oversight of compounding pharmacies for the safety of patients, these laws do not address the unique needs of ophthalmologists, particularly retina specialists, who use Avastin (bevacizumab, Genentech) to treat various ocular conditions, including age-related macular degeneration, diabetic retinopathy, vein occlusions, retinopathy of prematurity and neovascular glaucoma.
“[Some of] these blanket policies are going to negatively impact the physicians and the patients,” Kim said. “In particular, the proposed beyond-use date of 5 days for repackaged biologics, which includes Avastin, is too restrictive and makes it practically impossible to use Avastin for most ophthalmologists. It mandates that we have only 5 days to use the drug from the time it was repackaged at an outsourcing facility, but it does not account for the time to order and ship the drug to our practices and does not account for the days needed for sterility testing of these drugs. Also, this 5-day period seems quite arbitrary, since the literature shows that Avastin remains stable and sterile beyond 5 days. Limiting the access to Avastin means we will be left to use more expensive drugs only, which will not only increase the health care costs, but also result in some patients declining needed treatments because they cannot afford more expensive drugs. FDA should hear different groups’ voices and make logical decisions and consider exceptions as we give them the appropriate biological and safety data. When access to these drugs impacts so many patients, this is a big issue.”
Pharmaceutical consultant Barbara S. Fant, PharmD, voiced support for oversight of compounding pharmacies in light of recent growth and change within the industry.
“I think the extent of compounding pharmacies has definitely increased over the past few years,” Fant said. “There needs to be some sort of oversight, more than there was in the past, because I think the laws and regulations that were passed back then [did not foresee] the extent to which compounding pharmacy facilities would expand into their current role. The regulatory changes need to strike a healthy balance between making compounded drugs available and assuring the safety and quality of the compounded products that are provided.”
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