Return Plan for Unused Drugs Wallops Challenge

(CN) - Alameda County's new law requiring drugmakers to facilitate and fund the disposal of expired and unused drugs is not unconstitutional, a federal judge ruled.

The Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association, and the Biotechnology Industry Organization had claimed that the Alameda County Safe Drug Disposal Ordinance, which was passed in July 2012, violates the commerce clause of the Constitution.

The law, which is touted as the first in the country, requires producers of prescription drugs that are sold or distributed in the county to pay for and operate "take-back" programs that let consumers turn in unused medicine for disposal. Drugmakers that do not comply face up to $1,000 a day in fines.

U.S. District Judge Richard Seeborg found Wednesday that the ordinance, which is scheduled to take effect in November, does not discriminate against out-of-state companies or place an impermissible burden on interstate commerce.

"The ordinance applies to producers who elect to sell their products within Alameda County, regardless of where the producers are based or the product originates. Nothing in the structure of the ordinance targets producers on the basis of their location - they are being required to participate in providing take-back programs because they sell prescription drugs in the county, not because they are out-of-state actors," the 11-page decision states. "Nothing in the ordinance will require, as a practical matter, any producer to alter its manner of doing business in any jurisdiction outside Alameda County, although producers will be free to use programs that they may already be using elsewhere, provided they meet the standards of the ordinance."

The fact that most prescription drug producers are based outside of Alameda County is not sufficient to turn a local measure into one that impermissibly burdens interstate commerce, Seeborg found.

Drugmakers also failed to show that Alameda County ignored other opportunities to fund the take-back programs, according to the ruling.

"Arguing that an alternative regime would have no burden on interstate commerce does not establish that the minimal burden this Ordinance arguably imposes on interstate commerce 'clearly exceeds the local benefits,'" Seeborg wrote. (Emphasis in original.) "Defendants have adequately shown that the Ordinance serves a legitimate public health and safety interest, and that the relatively modest compliance costs producers will incur should they choose to sell their products in the county do not unduly burden interstate commerce."

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