B12 Solipsism

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Generic Drugs and the FDA

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In other corrupt-Washington-business-as-usual news, the pharmaceutical corporations have successfully protected their profits against generic drugs by convincing Washington to underfund the department of government regulators who approves generics. If they have no staff and no budget, generics can’t be brought to market, causing consumers and Medicare to spend more on non-generic drugs.

American consumers are waiting nearly a year longer for government regulators to approve new lower-priced generic drugs than they did in 2005.

The delays, caused by a growing backlog of applications at the Food and Drug Administration, may be costing consumers and the federal government hundreds of millions of dollars a year as they continue in some cases to pay for name-brand drugs even after their patents expire, industry analysts said.

[Click to continue reading New Generic Drugs Facing Longer Waits for Approval – NYTimes.com]

Currently, approvals are taking over 2 years to wade through. Obviously, this office of the FDA is not a priority.

With lawmakers preparing to meet at the White House next week to discuss ways to give more Americans access to health insurance, generic makers say that underfunding of the F.D.A.’s generics office is denying consumers access to more affordable drugs. The agency’s office of generic drugs has a budget of $51 million for fiscal year 2010, up from $41 million in fiscal 2009.

Executives at the generics meeting joked that government was spending less per year on reviewing applications for new generic drugs than the New York Yankees spend on the payroll of the left side of their infield. (Alex Rodriguez and Derek Jeter between them earned $54.6 million last year, according to ESPN).

but if Washington was serious about being cost-sensitive and fiscally responsible, they’d act already. Ultimately, delaying generic drugs ends up costing taxpayers more money

While accounting for the majority of drug prescriptions in the United States, generics represent just a fraction of the total cost of drugs. Generics accounted for 70.4 percent of the 2.9 billion prescriptions in the United States last year, according to IMS Health, a health information company. But they accounted for only about 15 percent of the $300 billion spent on prescription drugs in this country last year, IMS said.

The slowdown in new generic drug approvals ultimately hurts consumers — and government payers like Medicare — because prices stay higher when there are no or only a few generic alternatives to a branded drug, industry analysts said.

Sad state of affairs: almost as if pharmaceutical corporations like GlaxoSmithKline set national policy. Hmmm, maybe they do?

Written by Seth Anderson

February 20th, 2010 at 1:47 pm

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