Many of us have found generic medicines to be good alternatives to more expensive brand-name drugs. But sometimes, they are not available. If we need a certain pharmaceutical, we have no choice but to pay the higher price for the brand-name version.
There may be good, acceptable reasons for that in many situations. But sometimes, there are not.
U.S. Reps. David McKinley, R-W.Va., and Peter Welch, D-Vt., want to do something about that. They have introduced a bill aimed at making more generic drugs available.
Their proposal, the Fair Access for Safe and Timely Generics Act, would, in McKinley’s words, “thwart manipulation of the Food and Drug Administration’s drug safety regulations in order to block the production of generic alternatives to brand name medicines.”
That could save Americans as much as $2.35 billion a year, according to an estimate by the Congressional Budget Office.
Last year’s scandal over the EpiPen device, a lifesaver for many people with severe allergies, illustrates how much money can be involved.
In 2009, a two-pack of EpiPens cost about $100. But by last year, the manufacturer, Mylan Pharmaceuticals, had increased the tag to more than $600.
Other companies had applied for FDA permission to sell alternatives at much lower prices — but approval had been delayed.
No one wants the FDA to take chances with drug safety. But there is ample evidence that sometimes, that has nothing to do with delays in approval of some drugs and medical devices.
Sometimes, companies seeking to block approval of generic competitors throw roadblocks in the way of FDA approval. The McKinley-Welch bill is aimed at removing such obstacles.
As McKinley put it, “The high cost of brand name drugs should never force patients to make painful financial decisions. Medicine must be affordable to those who need it most.”