The Food and Drug Administration Modernization Act of 1997 (FDAMA) exempted “compounded drugs”…

The Food and Drug Administration Modernization Act of 1997 (FDAMA) exempted “compounded drugs” from the rigorous Food and Drug Administration approval process that new drugs must ordinarily undergo. Compounded drugs are “cocktails” whose ingredients are combined, mixed, or altered by pharmacists or doctors to accommodate patients with individualized needs. Congress exempted compounded drugs from the usual drug approval process because the high costs of going through the process would likely make compounded drug production financially unfeasible for many pharmacists, given the special-order nature of such medications. Providers of compounded drugs, however, were exempted from the approval process only if they adhered to certain conditions set by the FDAMA. These conditions required, among other things, that the providers not advertise or promote the compounding of any particular drug, class of drug, or type of drug. Congress adopted the advertising restriction because it believed that the inability to advertise the compounding of drugs would keep the amounts of compounded drugs produced from becoming large enough to compromise the integrity of the approval process that new drugs generally must complete. A group of pharmacies specializing in compounded drugs filed suit against the U.S. Secretary of Health and Human Services and the commissioner of the FDA, alleging that the FDAMA’s advertising restrictions violated First Amendment free speech rights. What type of speech did the FDAMA restrict, and what level of First Amendment protection attaches to such speech? Were the pharmacists entitled to win their case?

 

 

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