Duane Morris attorney successfully argues on behalf of pharmacies before the US Supreme Court: Court rules that the FDA Modernization Act of 1997 is unconstitutional on the grounds that it restricts commercial speech - Brief Article

Townsend Letter for Doctors and Patients, July, 2002

An attorney from the Chicago office of Duane Morris LLC, successfully argued on behalf of seven pharmacies before the US Supreme Court, which on April 29, 2002, upheld a ruling of the United States 9th Circuit Court of Appeals that the Food and Drug Administration Modernization Act of 1997 (FDAMA) violated the pharmacies' First Amendment rights.

Partner, Howard M. Hoffmann, the Duane Morris attorney representing the pharmacies, argued that the portion of the FDAMA that prohibits pharmacists from advertising, soliciting and promoting "compounded drugs," i.e., drugs that are legally altered to meet the needs of individual patients, was a violation of their First Amendment right of commercial speech. The Court agreed and upheld the original ruling, holding 5-4 that the speech restrictions were unconstitutional. This significant ruling marks one of the few times that the Supreme Court held an Act of Congress unconstitutional.

Compounded drugs make up about 10% of all prescriptions, represent a significant and often critical medical benefit to patients, and represent a significant amount of revenue for pharmacies. Drugs are compounded for a variety of reasons, such as substituting an ingredient that can cause an allergic reaction, altering doses, providing an easier form of delivery or adding flavor to make a child's medicine more palatable. The ruling was a major victory not only for the respondents, many of whom specialize in compounding drugs, but also for any pharmacy wishing to advertise and promote the fact that they are experienced in compounding specific drugs to meet patient needs.

"I could not be more pleased to be a part of this truly exceptional, landmark ruling," said Hoffmann. "I am gratified that the Court recognized that truthful, non-misleading speech regarding lawful activity is protected by the First Amendment. I feel both humbled and privileged to have represented these pharmacists who each exemplify the very highest degree of pharmacy professionalism. They were courageous and determined throughout the entire process, and I am delighted that the Court ruled in their favor and was able to see the unconstitutionality of the FDAMA."

The pharmacies originally sued in federal court in November 1998 when they were planning to continue distribution of promotional materials advertising their ability to compound certain types and classes of drugs, despite the ban on such advertising. The federal court ruled that the ban was unconstitutional, and that these offending sections be severed from the rest of the FDAMA. On February 6, 2001, a three-judge panel of the 9th US Circuit Court of Appeals agreed that the Act was unconstitutional, but ruled that the entire Act must be struck down. The government then appealed to the Supreme Court.

"We were of course, very gratified that the decision was in our favor," said George Malmberg, owner of Wedgewood Pharmacy in Sewell, New Jersey. "We felt as though we were well-represented and in very capable hands with Howard Hoffmann and Duane Morris, and we can now continue to inform prescribers and their patients of the specific compounded drugs that we can offer."

Duane Morris, which has a significant pharmaceutical practice firm-wide and specifically in the Chicago Office, represented these pharmacies from the very beginning of the lawsuit, throughout the appeals process, all the way through to the Supreme Court ruling.

"We are honored to have played such a significant role in this ruling," said Sheldon Bonovitz, chairman of Duane Morris. "Our firm is dedicated to and experienced in issues of the pharmaceutical industry, and we were pleased to be involved with this case from the beginning. Duane Morris is thrilled with the ruling and with the exceptional work of Mr. Hoffmann throughout the case."

About Duane Morris

Duane Morris LLP, recently ranked 75th among the 250 largest law firms in the country in The National Law Journal, is a full service law firm of more than 475 attorneys. The Chicago office comprises attorneys representing major US and international companies, as well as individuals and small and emerging businesses. The firm has additional offices in New York and Westchester County, New York; London; San Francisco; Philadelphia; Atlanta; Boston; Miami and Palm Beach; Wilmington, Delaware; Newark, Cherry Hill and Princeton, New Jersey; Harrisburg and Allentown, Pennsylvania; Houston; and Bangor, Maine. The firm's Web site may be browsed at www.duanemorris.com