ARLINGTON, Va., Feb. 6 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today expressed extreme disappointment over the Bush Administration FY 2007 budget's inadequate funding for the Office of Generic Drugs (OGD), an agency within the Food and Drug Administration (FDA) that is responsible for the review and approval of affordable generic medicines. Generics save consumers and public and private health care purchasers billions of dollars each year, and OGD's scarce funds could substantially delay consumers' timely access to these affordable medicines.
"The Administration's budget proposal is penny-wise and pound-foolish," said GPhA President and CEO Kathleen Jaeger. "Generic medicines provide billions of dollars in savings to state and federal programs, employers, insurers and consumers. This budget proposal jeopardizes those savings.
"Instead, the Administration should realize that the return on investment from increased OGD accountability and de minimus funding -- even in the amount of $15 million -- would pay substantial and long-lasting dividends for all Americans. For example, additional OGD funding could yield tremendous financial benefits for several of the Administration's health care priorities, such as Medicare, Medicaid and programs to improve children's health care, assist the chronically ill, and fight AIDS," Jaeger added. "Delaying access to affordable generics, whether it's days, months or years, hurts the health of this nation."
Because generics cost 30 percent to 80 percent less than brands, generic medicines stretch scarce health care dollars while providing the same medicine and same results. A one percent increase in generic utilization nationwide could save the United States $4 billion dollars annually.
In the FY 2007 budget, OGD is flat-funded at best, even though its workload has increased by a staggering 36 percent. OGD currently has a backlog of more than 800 generic drug applications, a number that will only grow as more than $100 billion in brand products are expected to lose patent protection by 2010.
In fact, this is the third fiscal year in a row that OGD's budget has been flat-funded. Although funding for OGD was increased slightly in FY 2003, the funds were not expressly earmarked for specific day-to-day operations on generic applications. As a result, most of the funds went to other agency initiatives. This year, FDA has further reduced the budgets for generic drug research contracts and information processing modernization for the generic drug program.
"It's outrageous to learn that one of OGD's two FY 2007 performance goals is to reduce the approval time for generic drugs by a mere two weeks for the top 25 percent of generic applications. And it's even more outrageous that FDA projects an increase in the median review time to 17.5 months for all other generic applications," said Jaeger. "Sadly, FDA believes that streamlining the review process is the answer. Yet, FDA fails to realize that over the years, OGD and the generic industry have worked successfully on collaborative efforts to streamline the approval process for generic drugs. And, we now have reached a saturation point on administrative efficiency.
"GPhA appreciates OGD's previous efforts to streamline the review process, including staff working overtime. Without additional OGD funding and agency accountability, however, Americans will continue to be denied timely access to affordable medicine.
"We certainly agree with the Administration's budget reference about the need to eliminate unintended loopholes in bringing cost-effective generic drugs to the marketplace. However, it is deeply disappointing that this year's lack of investment in OGD undermines the very goal the Bush Administration rightly extols," Jaeger concluded.
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 53% of the total prescriptions dispensed in the United States, but less than 12% of all dollars spent on prescription drugs. For more information about the generic industry, visit http://www.gphaonline.org.
FDA's budget is available at http://www.fda.gov/oc/oms/ofm/budget/documentation.htm.
Generic Pharmaceutical AssociationCONTACT: Andrea Hofelich, +1-703-647-2495, for Generic PharmaceuticalAssociation
Web site: http://www.gphaonline.org/
