FDA loses case against compounding
pharmacies on First Amendment grounds
Most Americans don't know that they can legally obtain certain drugs that are not FDA-approved at compounding pharmacies. The cost of these “compounded” drugs is often lower than what it costs to buy finished drugs made by pharmaceutical companies. The reason most Americans don't know about drugs available at compounding pharmacies is that up till now, the FDA said it was “illegal” for compounding pharmacies to promote the drugs they offered.
A Federal appellate court has just ruled that the FDA cannot restrict advertising by pharmacists who sell compounded drugs. The decision pitted the free speech rights of pharmacists against a Federal law aimed at restricting advertising of compounds that require a doctor's prescription, but aren't subject to the FDA's approval process.
In citing previous cases, the U.S. Court of Appeals for the Ninth Circuit Court (San Francisco) stated that “government prohibitions of truthful commercial messages are ‘particularly dangerous' and deserve ‘rigorous review.’”
In this case, the FDA contended that restrictions on ads for compounds were an attempt to balance the needs of individual patients with the protection of the broader public by “preventing widespread distribution of compounded drugs.”
In an opinion (that upheld a lower court ruling), Judge Cynthia Holcomb Hall wrote that “the government neither explains nor supports” its contention that wider distribution of compounded drugs would endanger the public. “In fact, most of the evidence runs to the contrary,” she wrote, noting that “compounding is not only legal under state law, but most states require their pharmacists to know how to compound.”
Judge Hall went on to say that the government offered “no evidence demonstrating that its restrictions would succeed in striking the balance it claims is a substantial interest, or even protect the public health.”