With generic drugs covering 80% of all dispensed drugs in the US, Democrats and Republicans seem split over a proposed FDA rule that would allow generic manufacturers to submit labelling changes within 30 days after discovering a new adverse event or safety issue.
In a hearing on Capitol Hill Tuesday, FDA’s CDER director Janet Woodcock called for a level playing field for generic and brand name drug manufacturers as the proposed rule would require generic manufacturers to step up their safety monitoring and warn the public if any new issues arise within 30 days. The updated safety issues would be disseminated online before the FDA makes a decision on a label change, which Democrats seemed to think would improve patient safety.
Woodcock said: “The impetus to look into this rule was the disparity between generic and innovator drugs – the standards for manufacturing and safety and efficacy and the standards of reporting should be the same for generics and brand name drugs. The FDA wants to level the playing field.”
However, industry groups such as GPhA (Generic Pharmaceutical Association), buttressed by the support of Republicans, said the proposed rule would drive up the prices of generics with new requirements, and create confusion among physicians and patients as labels would at times be different for the same drugs.
Chairman Joe Pitts (R-PA) said the proposal“undermines the sameness rule” that requires generic and brand drugs to be the same and “will result in multiple products having multiple safety warnings before the FDA reviews them. The FDA even admitted the rule will open the generics companies to more litigation and will cause the rise of prices in generics.”
Rep. John Shimkus (R-IL) also harshly questioned Woodcock over why the agency didn’t meet with industry, physicians or pharmacists, but did meet with trial lawyers prior to drafting the proposed rule - insinuating that lawyers shouldn’t be the ones driving change in the US health system. However, Rep. Henry Waxman (D-CA) clarified that all proposed rules can be commented on by any physicians or industry groups.
Democrats further defended the proposed rule, noting that it would merely add to the amount of safety information available to patients and physicians on generic drugs.
Rep. Paul Sarbanes (D-MD) said he’s “baffled as to what would be the issue with this rule” as it strikes the right balance in monitoring generic drugs.
“Right now the FDA advises generics manufacturers to update safety information at the earliest time possible though the actual time varies quite a bit,” Woodcock added. This proposed rule would therefore “minimize the amount of time and cause less confusion because there are no timeframes currently.”
Republicans, however, cited a Supreme Court ruling from 2011 in which both majority and dissenting opinions agreed that generic manufacturers cannot change labels without same labelling change at the brand level. Some Republicans, such as Rep. Phil Gingery (R-GA), questioned what has changed since that decision.
Woodcock further defended the FDA’s position and noted that in some cases there are generic drugs on the market without a brand name counterpart.
This proposed rule would give those generic companies the ability to rapidly change their labels, she added, noting that generic drug companies do not frequently submit new safety information to the FDA.
The comment period for the proposed labelling rule has closed and now the FDA will review the comments and possibly issue a final rule.