Selected Client Engagements

• Successfully challenged a decision by the Food and Drug Administration to impose pre-market approval requirements on the makers of positron emission tomography (PET) drugs. Syncor International Corp. v. Shalala, 127 F.3d 90 (D.C. Cir. 1997).



• Represented all segments of the nuclear medicine industry in negotiations with Congress, CMS and the FDA in reaching agreement on the regulation of and reimbursement for PET drugs and services.



• Drafted a voluntary inactive ingredient labeling guideline for the OTC industry which delayed Federal legislation for a decade.



• Created and trained company personnel for a state government relations program for a national chain of specialty pharmacies. The program cost was recovered the first time it was used.



• Created and managed a trade association, The Council for Advanced Agricultural Formulations, Inc., which successfully lobbied Congress to extend to new pesticide inert ingredients the same intellectual property rights available to manufacturers of new active ingredients.



• Represented an FTC-appointed divestiture trustee in the sale of a $70 million product, including drafting sale documents, intellectual property cross-license and manufacturing and supply agreements.



• Successfully urged Congress to insert language in an appropriations bill to require the NRC to reexamine a controversial program on behalf of an association of nuclear medicine professionals.



• Successfully responded to an FDA Warning Letter which claimed that an OTC drug manufacturer was selling an OTC product with a prescription-only indication.



• Successfully responded to an advertising substantiation request from the National Advertising Division of the National Council of Better Business Bureaus on behalf of a medical device manufacturer.



• Guided a Swiss OTC drug manufacturer through manufacturing changes necessary to respond to a Warning Letter concerning cGMP issues and avoided imposition of an Import Alert in the interim.



• Obtained dismissal on Federal preemption grounds of a series of false advertising cases brought in the California state courts against a group of OTC drug manufacturers.



• Negotiated the structure of the bill that became the Generic Animal Drug and Patent Term Restoration Act on behalf of a coalition of generic veterinary drug producers.