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STAT – New bipartisan bill would give FDA the power to add off-label uses to generic drug labels

STAT – New bipartisan bill would give FDA the power to add off-label uses to generic drug labels

A bipartisan duo of senators wants to give the Food and Drug Administration the power to add off-label uses to certain generic drug labels.


Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) introduced legislation late Thursday that would put in place new requirements on generic drug makers and FDA.


Right now, drug makers can only market a drug for a new use — like treating a different condition or offering a different dosage — if they spend the time and money to submit a label change to the FDA. Generic drug makers, however, can’t launch that process. Only branded drug makers can.


In some cases, when a brand drug is pulled off the market, the generic version is the only remaining product available. Then, there’s no incentive for the brand company to step in, and no way for the generic to do so.


“The result is that these drug labels get frozen in time,” FDA Commissioner Scott Gottlieb told Congress in April.


The new bill from Hatch and Bennet would allow the FDA to review existing data on off-label uses for generic drugs without branded competitors and, when there is sufficient evidence for a new on-label use, order a generic maker to change its label.


The Hatch-Bennet bill does not prescribe the types of data the FDA should weigh to determine when the evidence is sufficient enough to take an off-label use and put it on a label — just that it be sufficient enough to meet the FDA’s existing approval standards.


But Jeff Allen, president and CEO of Friends of Cancer Research, which supports a more streamlined labeling process in these cases, told STAT generic drug makers shouldn’t have to conduct additional studies.


Outdated labels are a big problem. So much so that the FDA’s drug center chief Janet Woodcock admitted in April that she “lives in fear” over the issue, as Inside Health Policy, a Washington-based news site, reported at the time.


In fields like oncology, doctors are often still amassing data on potential uses for a drug after the drug hits the market.

This leads to a proliferation of off-label uses. A recent study conducted by Friends of Cancer Research found that of 43 cancer drugs approved between 1999 and 2011, nearly 80 percent had at least one widely accepted off-label use.


Doctors are free to prescribe a drug for any use, regardless of whether its on the drug’s label, but drug companies can’t promote these uses without getting FDA approval.


It’s unclear how hard lawmakers will work to advance the bill, since Hatch is retiring at the end of the year.


But Kurt Karst, a director at Hyman, Phelps & McNamara who helped staff work on the bill, said he believes it is relatively uncontroversial and that Hatch would not introduce it if he did not have a plan to get it passed.


Hatch’s office did not respond to a request for comment.…