SEMINAR SHEDS LIGHT ON NEW REG'S AFFECTING PHARMACEUTICAL INDUSTRY
May 5, 2004(FORT LAUDERDALE, FL May 4, 2004) -- The law firm of Ruden, McClosky, Smith, Schuster & Russell, P.A. hosted an informative seminar in Orlando on April 30th addressing significant new laws governing pharmaceutical manufacturers, distributors and retailers. Attended by more than 50 representatives of the pharmaceutical industry, the full-day program addressed the myriad issues raised by the Florida Prescription Drug Protection Act of 2003. Also addressed were the many issues related to the increasing importance of pharmaceuticals in the overall delivery of health care items and services that are likely to affect manufacturers, wholesale distributors and retail pharmacies in the foreseeable future.
In addition to members of the firm's Health Law Practice Group, the guest speakers included Sandra Stovall, Florida Drug and Cosmetic Act Compliance Manager, Bureau of Statewide Pharmaceutical Services, Florida Department of Health; and Jodi Avergun, Department of Justice, Chief Narcotic and Dangerous Drug Section. Stovall presented an overview of the new laws and related enforcement measures .Jodi Avergun of the US Department of Justice cited the penalties drug companies and individuals could face for non-compliance.
'Pharmaceutical companies face some fairly significant new requirements in the areas of product registration and record keeping.' According to Stephen Siegel, an attorney with Ruden McClosky's Health Law Practice Group, 'The pharmaceutical industry is now subject to a panoply of regulations and risks that other segments of the healthcare industry have become accustomed to addressing.'
Florida's new legislation may seem to be good news for consumers who will have greater assurance of the integrity of their prescription drugs. Smaller companies, however, may find that the new compliance requirements will make it impossible to compete with larger companies. The long-term result could be shortages and potentially higher prices as the number of suppliers able to comply with the new regulations drops. 'Overall, I believe we will see less flexibility in the system and higher prices as the competitive landscape changes,' said Suzanne Sterling, a speaker and attorney in the Health Law Practice Group. Sterling added that "other states as well as the Food and Drug Administration are looking carefully at the impact of this new legislation on Florida's drug industry and on consumers".
In addition to the new Florida legislation, speakers Mike Lowe and Mark Schlein of the Ruden McClosky Health Law Practice Group addressed the interrelationship of the increased regulation of the pharmaceutical industry and oversight by the Florida Board of Pharmacy as well as the increasing scrutiny being paid by the Florida Medicaid Program.
Ruden McClosky's Healthcare Practice group provides services on behalf of individual and group practitioners, independent practice associations, management organizations, outpatient care facilities, nursing facilities and home health agencies, CORF's, hospital chains and pharmaceutical manufacturers and distributors. Ruden McClosky is a full-service law firm with offices throughout Florida including Ft. Lauderdale, Miami, Naples, Orlando, Port St. Lucie, Sarasota, St. Petersburg, Tallahassee, Tampa and West Palm Beach and one office in Caracas, Venezuela.
