FDA Proposes Suffixes for All Biologics; AIS Newsletter Examines Potential Issues

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In its Sept. 2015 issue, Atlantic Information Services’ Specialty Pharmacy News examines criticism of a new proposed rule from the Food and Drug Administration that would require all biologics to have a four-letter suffix.

In guidance released late last month, the Food and Drug Administration (FDA) proposed the addition of a four-letter suffix to the nonproprietary names of all biologics, and a proposed rule that laid out how those suffixes would be applied. In a blog post, the FDA explained that the proposed rule and guidance “address[es] two main issues: to help prevent inadvertent substitution (which could lead to medication errors)... and to support safety monitoring of all biological products after they are on the market, by making it easier to accurately track usage.” But the proposal was met with concern from the pharmaceutical industry. Atlantic Information Services, Inc.’s (AIS) Specialty Pharmacy News (SPN) examines the criticism in its Sept. 2015 issue.

One industry expert who declined to be identified tells SPN that it’s “difficult to work out whether what’s being proposed fixes” the problems that the FDA mentions. “If the issue is that the current [data tracking] systems do what” they are designed to do, “but data is not input accurately,…this doesn’t solve the problem.” The source continues, “FDA would appear to be assuming 100% accuracy in each setting,... replacing a known but very small risk with something of an unknown risk.”

Another potential issue is technological, the source tells SPN, since the suffix rule would essentially cause each biologic to have two unique names. Current databases do not have a mechanism for two identifiers of a product on the market, which is a problem because it’s “essential” that the “systems be designed and able to cope with what the FDA proposes.”

Lee Rosebush, a partner at BakerHostetler, expresses concern about existing products. “As a pharmacist, I can say that many prescribers have specific habits on how they write out prescriptions,” he tells SPN. “By changing names of products that are already currently available, the agency is asking manufacturers to immediately educate pharmacies and prescribers about the specific changes and for prescribers to break these habits.”

Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates, maintains that as long as stakeholders “include NDC [i.e., National Drug Code] numbers, proprietary name and nonproprietary name in their databases, nonproprietary names can be updated retroactively via an automatic search/change to the FDA-mandated format. However, it will be awkward if some stakeholders implement the FDA-mandated change retroactively while others do not. It may be awkward for stakeholders that do not retroactively change their files but prospectively must use the new FDA-mandated format, because different pre/post drug names complicate drug use trend analysis. There will also be a potentially confusing transition period.”

Visit https://aishealth.com/archive/nspn0915-01 to read the article in its entirety.

About Specialty Pharmacy News
Specialty Pharmacy News is a monthly newsletter packed with business news and management strategies for containing costs and improving outcomes related to high-cost specialty products. Designed for health plans, specialty pharmacies, PBMs, pharma companies, providers and employers, the hard-hitting newsletter contains valuable insights into benefit design tactics, specialty markets for certain conditions, formulary decisions, merger and acquisition activity, payer-provider partnerships, patient adherence strategies, and new products. Visit http://aishealth.com/marketplace/specialty-pharmacy-news for more information.

About AIS
Atlantic Information Services, Inc. (AIS) is a publishing and information company that has been serving the health care industry for more than 25 years. It develops highly targeted news, data and strategic information for managers in hospitals, health plans, medical group practices, pharmaceutical companies and other health care organizations. AIS products include print and electronic newsletters, websites, looseleafs, books, strategic reports, databases, webinars and conferences. Learn more at http://AISHealth.com.

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Jill Brown, Executive Editor
Atlantic Information Services
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