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Protecting Patient Safety

Protecting Patient Safety
By voice vote the House of Representatives recently passed HR 1919, the Safeguarding America’s Pharmaceuticals Act. The bill would, among other things, expand the FDA’s regulatory authority to track the distribution of prescription drugs. The bill’s sponsor, Rep. Bob Latta (R-OH) said that the bill would help safeguard against counterfeit drugs by replacing a patchwork of federal and state regulations.

 At the same time committee members rejected an amendment sponsored by Rep. Frank Pallone(D-NJ) that would have required an electronic system to monitor the distribution of prescription drugs down to a more specific unit, rather than lot, level.

The bill’s passage provides a cautionary tale about how the current political divide in Washington has opened a chasm into which the interests of ordinary people seem to have fallen.

According to a Bloomberganalysis, the bill is a reaction by House Republicans to last fall’s deadly meningitis breakout. They believe that part of the reason the disease spread was a failure by food and drug authorities to adequately enforce existing laws. Given what Republicans see a regulatory failure, they’re not inclined to give regulators even more power, goes the analysis.

But Democrat lawmakers are concerned about the lack of electronic monitoring -requirements in the bill.  California Democrat Henry Waxman says the bill doesn’t go far enough to protect the existing drug supply chain.

The Democrat-controlled Senate’s version of the bill, S.959, the Pharmaceutical Compounding Quality and Accountability Act, would crack down further on counterfeit drugs by tightening regulations on manufacturers. It would also give the FDA a clearer role in overseeing commercial compounding manufacturers, according to Bloomberg.

Given the wide differences between the two bills, getting a bill out of conference could pose a challenge, says Bloomberg analyst Brian Rye.

So there you have it: the Republicans’ light hand on federalizing policing powers, the Democrats’ belief in the ability to manage every problem from Washington, and the regulators uneven record in managing existing mandates. The perfect storm of inaction. Where have we seen this before?

The problem this time is that peoples’ lives are at stake. In three months students head back to school all over this large country, packed into schools and dorms and apartments where communicable diseases can spread like a California wildfire. This is a bill where both sides can get together and look like heroes. It’s one where they may want to forgo how they look in their respective party caucuses in favor of how they look to the only caucus that should really count—the people who sent them to Washington in the first place.