Get off the fence, FDA, and deal with generic labeling

I’m not a fanatical cheerleader for the pharma and biotech industry—nor for government agencies like the U.S. Food and Drug Administration (though I admit to a huge soft spot for the National Institutes of Health). And frankly, that’s a good thing, as I’m supposed to be at least marginally impartial and objective (I’m into that old-school journalism that seems out of favor these days on the cable news networks and some of the newspapers too).

That said, I’ve defended Big Pharma against rants about pharmaceutical company greed from parents on the playground and people at dinner parties over the years. I’ve pointed out the huge R&D costs and significant failure rates they endure.

In a similar vein, I’ve rolled my eyes many times at the emails I often get from Public Citizen when they sharply criticize the FDA for approving a drug that they think is dangerous, inadequately studied and/or insufficiently vetted. Mainly because I don’t recall them ever having a nice thing to say about an FDA approval. (Nothing against public advocacy groups, mind you; I’ve done work for a few in the past.)

But at the moment, I think Public Citizen has a good point. And after saying such nice things about FDA and its approvals last year in the January issue cover article, I’m going to talk a little trash about them now—over a generic labeling rule. Or, as Public Citizen put it: FDA delay in safety rule leaves patients nationwide at risk.

As the organization explains, the FDA’s postponement to July 2016 of a significant patient safety rule—proposed in 2013 in response to a 2011 Public Citizen petition—leaves open “a safety gap for the millions of patients who take generic medications … Currently, brand-name manufacturers are permitted to make safety updates without prior FDA approval. But generic manufacturers are not permitted to update warnings to reflect new safety information unless instructed to do so by the FDA.”

The FDA’s proposed rule would solve that problem, Public Citizen notes, by giving generic manufacturers the option to update labeling to provide warnings about newly discovered risks to patient safety without prior FDA approval, just as brand-name manufacturers have been able to do for close to three decades.

“The FDA has not yet finalized the labeling rule and has several times delayed its expected completion date. In its recently issued regulatory agenda, the FDA has now pushed the date back even further, to July 2016,” Public Citizen noted, with Dr. Michael Carome, director of the Public Citizen Health Research Group, going on to say, “The agency should resist pressure from the pharmaceutical industry and finalize a rule that will protect patients. The agency should move expeditiously to finalize its proposed rule, which will better protect patients by ensuring they have timely access to updated safety information.”

The FDA’s proposed rule reflects the reality that information about serious risks often comes to light after generic versions of a medication are on the market, as documented in a 2013 Public Citizen report, with the organization explaining, “Under a longstanding FDA rule, adopted in the 1980s at the urging of the pharmaceutical industry, brand-name manufacturers are permitted to make safety updates without prior FDA approval. That rule enables updated warnings to reach physicians and patients as soon as possible. After generics enter the market, however, brand-name market share drops precipitously, and brand-name manufacturers are much less vigilant about labeling updates. Further, brand-name manufacturers often stop making a product for which there is a generic version and, at that point, are not monitoring the product or considering labeling updates.”

OK, I’ve let Public Citizen have its say; here I am with the follow-on.

The fact is, the FDA expects makers of generic drugs to prove comparable efficacy, bioequivalency and the like to ensure their products meet the muster the previously patent-protected products did. So too should they have similar powers and abilities related to safety labeling.

After all, we have a lot of concerns about things like cardiac effects of drugs in recent years (a topic we touch upon in a story on page 24). What good are things like that kind of work or Phase 4 studies or gathering patient outcomes data or any of that, if we’re not going to let the generic drug companies let us know about potential drug issues in a timely fashion?

Shorter version: Get off your duff, FDA, and show use the same kind of action here on labeling as you did with novel drug approvals and rare disease treatments last year.