GPhA - Legislation Promoted as a Countermeasure Against Bioterrorism Would Counter Bipartisan Measures to Constrain Prescription Costs Cites unwarranted provisions that would unnecessarily and excessively increase nation's Rx drug bill by tens of billions of dollars a year.
The Generic Pharmaceutical Association (GPhA) today issued a strong warning to the Senate that biodefense legislation (S. 3) in its current form would effectively extend patents for marketed drugs and delay access to more affordable generic medicines - unnecessarily increasing prescription drug costs to consumers, businesses, and government purchasers by tens of billions of dollars a year.
"The legislation in its current form would provide enormous profits to brand companies by keeping affordable generic medicines off the market, leaving consumers and private and public purchasers to foot the multi-billion dollar bill,"" said GPhA President and CEO Kathleen Jaeger. "It is outrageous that under the guise of homeland security, the brand pharmaceutical industry is seeking patent extensions for everyday medicines at the expense of consumers, especially seniors and the uninsured -- individuals who need affordable, life-saving generic medicines the most."
S. 3 is intended to strengthen America's preparedness to bioterrorism through measures that accelerate the research, development and manufacture of novel countermeasure agents. It contains promising incentives, such as needed product liability protections, expanded tax incentives, and fast track FDA review of drug applications, which GPhA supports. However, it also includes provisions that would provide substantial and unnecessary windfalls to the brand pharmaceutical industry, impose a tremendous, and needless burden on the nation's health care system, and offer little enhancement to overall national security.
Specifically, GPhA opposes provisions in the legislation that:
-- Define a countermeasure so broadly that almost every drug in most people's medicine cabinets would qualify. Commonly prescribed drugs that treat headaches, nausea, and depression would be eligible for patent extensions with minimal testing performed by the brand manufacturer. Patent extensions on these products would put the healthcare system in crisis by adding tens of billions of dollars in expenditures on these already profitable drugs.
-- Would allow for a "wild card" patent extension when a company has a countermeasure product approved (even for a secondary use to treat a common ailment like headaches). This "wild card" in effect transfers the awarded patent extension to any other product the company manufactures. For example, if Pfizer were to have a countermeasure labeling statement approved for an already existing product, it could reap up to two extra years of patent monopoly for a different blockbuster drug. The company also could license a product for which another drug company performed all the requisite research and development, yet still receive another wild card. The wild card could be applied at any time before patent expiration, creating uncertainty for generic companies to invest in the requisite development of affordable medicines.
-- Allow for unlimited patent extensions per product. Under current law, only one patent can be extended for developing a novel drug product. Under S.3, multiple patents claiming the brand drug can be extended, forcing consumers to pay monopoly prices for many years to come and keeping generics off the market.
-- Would extend the patent terms of products that qualify as countermeasures up to the full amount of time from when the patent is issued until the product is approved. Current law balances innovation and access by providing only 5 years of the regulatory review period to be added to the patent's life. If a company were given the full review time under an unlimited regulatory review period, it could add a decade of patent exclusivity and monopoly pricing per brand product. Moreover, providing patent extension for the full development time is contrary to the intent of the goal of expediting research and development.
-- Enable brand companies to be rewarded for the simple testing for new indications of currently marketed drugs, even if the federal government already has determined which everyday medicines are effective countermeasures for known bioterror threats. For instance, the Centers for Disease Control, the National Institutes of Health and Department of Defense provide a wealth of information on currently available products to use in case of exposure to many forms of biological and chemical agents. Since the research already has been performed at taxpayers' expense, there is no reason the brand pharmaceutical company that manufactures the product should be given any additional market protection on that product or any other product.
"As drafted, S. 3 threatens the economic viability of the nation's health care system by penalizing new generic drug development, offering wild card exclusivity, and unnecessarily extending current patent terms. These proposals have been previously rejected by Congress as catering to special interests at the public's expense," said Jaeger. "These provisions will pose major economic challenges to already overburdened employers, insurers, consumers, and government programs such as Medicare and Medicaid. Given the growth in the number of uninsured Americans, serious deficits in Medicare and Medicaid programs, soaring health insurance premiums, and the numerous other crises facing the health care system, the financial and health care impact of S. 3 would be disastrous.
"GPhA is looking forward to working with Congress to remove these onerous provisions from the bill and to help support the overall goal of securing America," Jaeger said. "No industry is more committed than the generic drug industry to protecting public safety, ensuring access to affordable, high-quality pharmaceuticals, and rewarding true innovation."
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 51% of the total prescriptions dispensed in the United States, but less than 8% of all dollars spent on prescription drugs. The Generic Pharmaceutical Association is committed to improving lives for less. For further information, please contact GPhA at 703-647- 2480, or visit our web site at http://www.gphaonline.org.
