The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) regulates drug manufacturing, marketing, and distribution, providing that no person may sell any new drug unless approved by the Food and Drug Administration. The Food and Drug Administration Modernization Act of 1977 (FDAMA), which amends the FDCA, exempts compounded drugs from the FDCA’s requirements provided the drugs satisfy a number of restrictions, including that the prescription must by “unsolicited,” and the provider compounding the drug my “not advertise or promote the compounding of any particular drug, class of drug, or type of drug.” The plaintiffs, a group of licensing pharmacies that specialize in drug compounding, filed a complaint in the United States District Court for the District of Nevada, contending that these restrictions are unconstitutional.
1. Highlight the pertinent facts;
2. Identify the issue of law posed by the case problem;
3. What should be the decision in the case?
4. The reasoning for such decision