The AARP says that a "doughnut hole" in Medicare prescription plans could be causing senior citizens to pay large amounts or go without needed medicines.
The organization, which advocates for people 50 and older, is lobbying lawmakers this month to create more affordable health care for senior citizens. This week, that focus is narrowed to making biologic drugs more affordable.
Elizabeth Pyron, coordinator of the Georgia Cares program at Legacy Link, the Area Agency on Aging in Gainesville, traveled Wednesday to Washington, D.C., to speak with U.S. lawmakers, including Rep. Nathan Deal, R-Gainesville, about the difficulties the lack of generic biologic drugs pose for Medicare patients.
Biologic drugs are those created from other organisms by harnessing natural processes within those cells to produce specific compounds that are beneficial, according to Brian Cummings, a toxicologist in the University of Georgia’s school of pharmacy.
The drugs can range from vaccines to hormones and are usually those used to treat such diseases as Alzheimer’s, multiple sclerosis and cancer, Cummings said.
The AARP has endorsed a bill Deal is co-sponsoring with Rep. Henry Waxman, D-California, that would create a Food and Drug Administration approval process for generic versions of these biologic drugs.
In a news release, the AARP said the bill would help close the "doughnut hole" in the Medicare Part D prescription drug plan that forces more than 3 million people to pay their full drug costs each year.
Cummings, who studies the types of toxicological issues that arise from creating generic drugs, also said he thought the idea of creating an approval process for generic biologics was "an excellent thing."
"There has got to be standards that need to be followed (in creating generic biologics) to prevent future toxicities," Cummings said.
One reason the drugs are not offered generically yet could be because of the amount of time and money pharmaceutical companies spend creating the drugs, Cummings said.
"Companies spend a lot of money — billions, I mean billions — into creating a drug — I don’t even think the public realizes — and getting it to market," Cummings said.
In the past, the FDA has said the approval of generic biologics is not as easy as approving generic chemical drugs.
A statement FDA Deputy Commissioner and Chief Medical Officer Janet Woodcock made before the House Subcommittee on Health, Committee on Energy and Commerce in 2007 outlined the challenges with approving follow-ons, or generic biologics.
Although Woodcock did say that the FDA had some experience with reviewing some biologic drugs, she said that biologic drugs are difficult to manufacture consistently, therefore making the follow-ons difficult to regulate. She said the current approval process for generic chemical drugs, which relies on finding the same active ingredient, would not apply to biologics.
"Because of the variability and complexity of protein molecules, current limitations of analytical methods and the difficulties in manufacturing a consistent product, it is unlikely that, for most proteins, a manufacturer of a follow-on protein product could demonstrate that its product is identical to an already approved product," Woodcock said, according to a statement published on the FDA’s Web site.
But not having some of these key biologic drugs available generically could be detrimental for those people on Medicare prescription plans.
"Prescription drug coverage has literally been a lifesaver for people in Medicare, but the widening doughnut hole is still leaving too many Americans on their own to face skyrocketing drug costs," said AARP Executive Vice President Nancy LeaMond in the news release. "We know that higher costs lead people to skip doses or give up their prescriptions entirely, putting their health in jeopardy and driving up long-term costs."