On Monday, Congress passed a bill to “give the Food and Drug Administration more power to police compounding pharmacies” by subjecting them to, “rules on quality control and oversight.” It’s not complete FDA authority, but "'It has very sharp teeth,' said Sarah Sellers, a drug safety consultant who has tracked the issue for years."
Seems like this is a positive step. You many recall that, “Just over a year ago, tainted injectable drugs from a compounding pharmacy in Massachusetts caused a meningitis outbreak that killed 64 people across the country, according to the Centers for Disease Control and Prevention.” (See our earlier coverage here, here.)
Much to the shock of most people, even though “[e]ighty percent of hospitals outsource some part of their sterile compounding,” the FDA does not regulate these facilities. Now it will, at least to some extent. Plus, writes the Times,
[M]anufacturers that are F.D.A.-approved generally carry [product liability insurance]. The insurance helps when something goes wrong with a drug. Ordinary pharmacies do not have to have such insurance.
But here’s the thing. Continues the Times, “The F.D.A. … expressed disappointment that [the bill] fell short of giving the agency fuller regulatory power.” The agency says it wants more power over compounding pharmacies. OK. But then I read his: it wants to relinquish authority over dangerous medical devices. Don't get it.
From the New York Times Wellness Blog:
In recent years, Congress has directed [the F.D.A.] to put … high-risk devices through rigorous testing or to change their classification. To the consternation of several consumer watchdog and patient safety groups, the F.D.A. has proposed changing the classification of many of the products so they are no longer considered high-risk, or to vary their classifications depending on their use. Either way, they could still be sold without going through premarket approval.
Among high-risk devices to be “downgraded” are external pacemakers, access tubes implanted in blood vessels, a component of a lung device used for newborns, dental devices that are implanted near the brain, and screw systems used in spinal surgery. …
In a statement to The Times, F.D.A. officials said that “every medical device comes with a certain level of risk, whether it is a pair of crutches or a heart valve.”
Here’s the only good thing I can see coming from all of this. If a device no longer receives FDA pre-market approval, then patients injured by such devices may get their legal rights back. That’s according to the SCOTUS in the 2009 case, Reigel vs. Medtronic. Clearly, they’re going to need them.