BACK of the BOOK
The Hidden Costs of Cheap Drugs
In Bloomberg, regulators and legislators weighed in on
America’s “love affair with cheap drugs,” questioning
whether approaches to bringing down prices – like
fast-tracking generic drug approvals – are coming at
the expense of U.S. Food and Drug Administration
(FDA) oversight that ensures the safety and
effectiveness of drugs already on the market.
“It’s not the number of inspections we do, it’s whether we’re targeting
effectively. … There are certain actors that are more likely to do something
deliberate – and those are the ones that you need to be focused on.”
—FDA Commissioner Scott Gottlieb, MD, on the agency’s “surgical approach”
to selecting facilities to visit
“Americans need to know that their medications are safe and effective. It’s the
FDA’s job to ensure that, from the factory floor to the shelves of our pharmacies.”
—Rep. Diana DeGette (D-CO), chair of the House’s investigations subcommittee
with oversight of the FDA
“I think our oversight is better than it’s ever been. That’s my professional
judgment of manufacturing worldwide. We know where they are, we know
who they are, we know what they’re making, we know when we’ve been
there, we know who else has been there. Could we improve? Yes, but I
wouldn’t look at absolute stark numbers and say that should be a greater or
lesser cause for concern.”
—Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research,
on concerns about global manufacturing oversight