OAKLAND, Calif. (CN) - A federal judge refused Thursday to block the nation's most popular drug database from classifying prescription prenatal vitamins as over-the-counter, which opponents say will deny millions of women access to supplements that prevent birth defects.
U.S. District Judge Haywood Gilliam Jr. found First Databank's coding change does not make its description of prenatal vitamins "false and misleading" or cause irreparable harm to the vitamin supplier that sued it in the Northern District of California.
"That plaintiff would prefer defendant to organize its information or code plaintiff’s products differently does not render the database false or misleading," Gilliam wrote in his 25-page ruling.
New Jersey-based vitamin supplier Exeltis USA sued First Databank in August, claiming its reclassification would cause Medicaid and private insurers to deny coverage of essential supplements.
Although prenatal vitamins are readily available over the counter at any pharmacy, some insurance companies will not cover the cost of over-the-counter drugs or supplements.
Exeltis calls First Databank "the gatekeeper" for prescription drug reimbursement because eight of the nation's top nine pharmacy benefit managers rely on its database.
First Databank, a St. Louis-based subsidiary of Hearst Communications, says it made the coding change based on guidance from the Food and Drug Administration, which held that medical foods cannot be properly labeled as "prescription only."
Under First Databank's revised classification, code "F" describes "drugs that are prohibited by federal law from being dispensed without a prescription."
This does not apply to prenatal vitamins, First Databank argued.
Exeltis says the reclassification affects millions of women, especially those on Medicaid, who depend on access to those vitamins to prevent birth defects like spina bifida and anencephaly - the latter of which can cause babies to be stillborn or survive only a few hours after birth.
But Gilliam found insurance companies, not the database, ultimately decide whether to cover prenatal supplements prescribed by a doctor.
"Plaintiff assumes that payors will abandon their independent obligations to determine which products they must cover under federal law," Gilliam wrote.
Gilliam acknowledged a disconnect between the FDA's guidelines for approved "prescription drugs" and the Medicaid Act's requirement that state programs cover "prescription prenatal vitamins."
However, he also found that no federal law requires prenatal vitamins be dispensed by prescription only, which means First Databank's coding for the supplements is not inaccurate.
While Exeltis failed on its motion to block the prenatal vitamins’ current coding, the judge found it did make a strong enough case to move forward with its lawsuit.
Gilliam denied First Databank's motion to dismiss the case, finding Exeltis' suit has "minimal merit" to survive a motion to strike under California's anti-SLAPP statute. The anti-SLAPP law aims to prevent lawsuits that would punish entities for exercising their First Amendment speech rights.
Gilliam questioned whether drug descriptions in a database would qualify as "commercial speech," which is exempt under the anti-SLAPP statute. But the judge ultimately concluded the use of drug coding for "reimbursement decisions may suggest that the database is commercial in nature."
Exeltis attorney Benjamin Mundel, of Sidley Austin in Washington D.C., declined to comment on the ruling.
First Databank attorney Thomas Burke, of Davis Wright Tremaine in San Francisco, did not immediately return a phone call seeking comment.
A case management conference is scheduled for Jan. 10 in Oakland.
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