PRNewswire, January 6, 2006

Safety and Economic Risks Outweigh Benefits

SAN DIEGO -- Leaders from California's life science industry today expressed concern over the portrayal of the importation of prescription medicines in the governor's state of the state address last night. The Governor's new importation position, referenced in that speech and in an earlier letter to congressional leaders, calls for the government to permit the importation of prescription drugs, which puts both patients and California's life science community at risk.

"While we respect and applaud the governor's efforts to come up with ways to improve health care access, the importation of pharmaceutical products from foreign countries is not the simple answer it seems," said Jack Lief, chairman of the board of BIOCOM and president and CEO of Arena Pharmaceuticals, a biotech company located in San Diego. "Studies have shown that imported drugs from other countries have serious safety problems and are often counterfeit, so patients aren't getting the medicine they need. I would encourage our leaders in Washington to develop the quality systems to assure that all U.S. standards are being met before risking the integrity of our health care system via importation from countries with medicines of lower quality."

Recent investigative operations from the U.S. Food and Drug Administration have found that imported drugs from foreign countries often come from different locations than can be counterfeit, super or sub potent, or improperly labeled, meaning patients are at risk every time they take a medicine that is supposed to make them better, said Peter Pitts, senior fellow for health care studies at the Pacific Research Institute and former FDA Associate Commissioner for External Relations.

"In a recent FDA 'sting' of products being shipped into the U.S., the FDA found that 85 percent of the drugs sourced as 'Canadian' were not," said Pitts "These were shipped from 27 different countries, and the products' purity, safety and efficacy could not be verified, with 32 of the drugs tested found to be counterfeits. Patients are taking a risk with their health if they cannot be certain they are receiving the medicines their doctors prescribe." The Governor's letter to congressional leaders earlier this week discussed many of the safety and economic issues associated with drug importation, including the potential damaging effects it could have on California's life science community.

"We commend Governor Schwarzenegger for recognizing the financial burden placed on the United States with regard to research and development, but drug importation is not the answer and will only hurt future research and innovation in the California biotechnology industry," said Randy Woods, president and CEO of NovaCardia, a San Diego life science company. "We strongly encourage the governor to re-think his stance toward drug importation and to realize the economic damage it will cause our state, which now leads the world's life science industry." Innovation is the key to the biomedical community's success. Importation puts this advanced drug research at risk due to its reliance on trade with foreign countries that enforce price controls to artificially hold down the cost of prescription medicines. Members of the international community should be brought to understand that the U.S. is unfairly subsidizing the cost of research and development of new drugs, and price controls simply shift the financial burden of drug research on other countries.

"Governor Schwarzenegger is correct when he says that Congress should call on foreign nations to eliminate price controls on prescription medicines," said Dr. Stephen Chang, president and CEO of MultiCell Technologies. "All members of the international community would then pay their fair share for biomedical prescription medicine research and development. Importation of foreign price controls into the U.S. will have a detrimental impact on the biomedical community's ability to fund future research and stalls the development of innovative therapies."

Chang continued, "The Governor's actions and statements regarding importation also highlight his concern about the challenges of providing access to medicines to Californians who lack adequate insurance coverage for prescription medicines. While we share the Governor's concern about this extremely important challenge, importation of prescription medicines from foreign countries is not the answer to providing access to quality health care coverage that includes a focus on wellness and prevention. We look forward to engaging him in a productive dialogue to find solutions to this challenge."

Web links:

Governor Schwarzenegger's letter: Governor Schwarzenegger Calls on Federal Government to Allow Consumers to Safely Import Prescription Drugs

FDA information on imported and counterfeit drugs: http://www.fda.gov/importeddrugs/

BIOCOM represents the Greater San Diego and Southern California life science community and is the largest regional life sciences association in the world, representing more than 470 member companies. BIOCOM seeks to position the Greater San Diego life sciences community to achieve individual and collective success on the world stage of scientific and technological innovation, and in the development of products that improve global health and quality of life.