Endo lobbies Congress for additional tests to prove generics’ quality

It’s a difficult time for brand-name drugmakers. Research and development costs have increased. And patents are expiring on some of the biggest products around — most famously, the cholesterol pill Lipitor.

That’s raised skepticism as a local pharmaceutical firm recruits big names to lobby Congress on a bill to speed generic drugs through the regulatory approval process.

The New York Times reports that Endo Health Solutions, formerly known as Endo Pharmaceuticals, wants the bill to require generic drugmakers to pay for independent tests to confirm their products are really equivalent to the name-brand drugs.

The firm, headquartered in Chadds Ford and which underwrites on WHYY, has a brand-name pain reliever, Lidoderm.

Endo’s hired help in Washington includes former Michigan Congressman Bart Stupak. The change would impose additional fees on generic-makers to pay for tests.

“It potentially could be a strategy in order to delay generic entry or make generics more costly,” says George Chressanthis, a professor at Temple’s Fox School of Business who formerly worked for several large pharma corporations.

“On the other hand, the other issue is to ensure that, in fact, if there is a bio-equivalent drug — that’s a generic drug that’s going to be on the market — is it truly bio-equivalent,” he says.

Chressanthis says if that’s not the case, the original drugmaker can run into legal trouble.

Mylan Inc., a Pennsylvania-based generics manufacturer, has provided key support for the main bill to speed approval of generics. The company declined to comment. Endo did not respond to calls.