Summary of Thompson v. Western States Medical Center, 535 U.S. 357 (2002)
Facts: FDA Reg exempt “compounded drugs" from regular drug approval standards if providers followed advertising and promo restrictions regarding those drugs. Resp. group of pharmacies.
Drug compounding is where doctor or pharmacist combines ingredients to form new medicine for a specific need.
Issue(s): Whether the FDA compound drug Regs constitute an abridgement of the Respondent’s 1st Amend Commercial Speech protection?
Holding: sec. 503A’s provisions regarding the ban on Ads and Promotions are UnConst’ restrictions on Comm Speech.
Procedure: Resp sought injunction against enforcement of Ad sections. D Ct granted Mot 4 Summary; Ct of App Affirmed. U.S.S.Ct Affirmed.
Rule(s): 1st Amend
Rationale: Parties agree that Adv and Promo restrictions involved are Commercial Speech. Apply Central. There’s no challenge to 1st prong-lawful and truthful.
B/c Govt concedes that the cost of obtaining approval for compounding would eliminate compounding as a practice, Govt must draw a line distinguishing btwn small-scale compounding and large-scale manufacturing. Govt failed to show that the speech restrictions are no more extensive than necessary to serve the asserted interests.
There’s nothing in Legis Hx or Brief explaining why Govt believes the ban on Ads was necessary as opposed to merely convenient to reach its asserted interests. Govt bears the burden of proving “substantial interest" as well as proof the means ‘directly advance that interest," and it is no more extensive than necessary to serve that interest. Fear that Advertising compound drugs would put people at risk who don’t need them b/c Ads would convince Drs to prescribe does not justify the restriction on speech. Govt cannot ban dissemination of truthful information to prevent People from making bad decisions.
The Amt of Speech banned alone caused this law to be held UnConst’l. It prevents pharmacists from telling Drs treating Clients w/ special needs about alternative drugs. FDAMA prohibits useful speech and does not appear to directly further any Govt objective asserted.
Pl’s A: (Govt) Govt has three (3) Int: Preserve the effectiveness and integrity of approval process and protect public; Preserve availability of compound drugs for individual patients in need; and Achieve balance btwn both Int which is itself an interest. The FDCA requirements are critical to public safety and health. FDAMA speech related provisions provide distinguishing line that directly advances GI.