Generic Firms Create New Association
The leading generic pharmaceutical trade associations have formed the Coalition for Affordable Pharmaceuticals (CAP), a new organization that will work to increase consumer access to high-quality generic pharmaceuticals.
The Generic Pharmaceutical Industry Association (GPIA), National Association of Pharmaceutical Manufacturers (NAPM), and National Pharmaceutical Alliance (NPA) will pool resources to expand consumer access to generic drugs. CAP will educate consumers about the benefits of generic drugs, provide accurate and timely information about issues that affect patient access to generics, and promote legislation to improve consumer access to generic drugs.
According to NAPM President Bob Milanese, CAP will implement a public awareness campaign to inform consumers and policy makers that FDA-approved generic drugs are therapeutically equivalent to their brand-name counterparts. "The only difference between generic drugs and brand name drugs is the price," he said, "and ours cost less."
Generic pharmaceuticals enter the market at an average price of 30% less than their brand-name equivalents. The average saving increases to more than 60% after two years.
"By providing lawmakers and regulators with accurate information about the safety, efficacy and cost-effectiveness of therapeutically equivalent generic medicines," added Alice Till, President of GPIA, "CAP will help improve the delivery of effective health care and control costs for millions of Americans."
The coalition will promote federal legislation to help consumers obtain generics more easily. NPA President Christina Sizemore indicated CAP will also expose "tactics" used by the brand-name drug industry to impede consumer access to more affordable generic pharmaceuticals. "Consumers and taxpayers are facing a 'generic blockade' that only Congress and state legislators can stop," she said. "Our joint effort is intended to end the blockade."
One of CAP's pet issues is approval of generic pharmaceuticals. By law the FDA must approve off-patent drugs within six months, but approvals normally take three times that long. According to Dianne Dorman, a spokeswoman for the Generic Pharmaceutical Industry Association, 125 U.S. Food and Drug Administration employees handle the large and growing regulatory needs of generic manufacturers, compared with 1,763 employees for branded drugs.
Yes, approving a new drug involves much more red tape than approving a generic, but approval numbers indicate a strong FDA manpower bias in favor of branded drugs. New Drug Applications (NDAs) totaled 235 in 1997, compared with 223 in 1993, whereas 321 generics were approved in the same year (up from 219 in 1994). To alleviate the approval bottleneck CAP is seeking to increase funding to FDA's Office of Generic Drugs by $3 million per year.
CAP faces an uphill battle as drug giants grow in power and influence, both in legislative halls and in the marketplace. Managed care organizations, for example, offer patients small incentives for choosing generics. So in the age of prescription cards consumers will likely choose the established product when there is little or no difference in price. One possible remedy, says Dorman, is to offer consumers meaningful dollar incentives to choose generics, a policy that will benefit both the patient and the managed care organization.
CAP will announce details of its legislative agenda and public affairs campaign in the next few weeks.
For more information: Bradley Cameron, Coordinator, Coalition for Affordable Pharmaceuticals, 4530 Wisconsin Ave. NW, Suite 340, Washington, DC 20016.
By Angelo DePalma