The federal government re-ignited a controversial proposal to give generic drug makers the power to unilaterally update product labels to reflect new safety information, a proposal that drew criticism from Congress and the generic drug industry.
The Food and Drug Administration said Tuesday it plans to hold a public meeting on March 27 and wants more comments on a proposal to overhaul how generic drugs are labeled.
The agency proposed back in November 2013 that generic drug makers could change their labeling without FDA approval if a safety issue comes up, even if that labeling differs from that of the branded drug. This way doctors and nurses would learn about safety problems much sooner as generic drug makers won’t have to go through the month-long approval process, the agency said at the time.
Brand drug makers already have the power to make such changes.
The call for a public meeting and comments is the first action the federal government has taken since the proposed rule was introduced.
It could be a sign that the agency is starting to have doubts about the change, said James Czaban, a partner with the law firm Wiley Rein and an expert in pharmaceutical law.
Another possibility is the government believes the change will be challenged in court once it is finalized, Czaban told the Washington Examiner.
The agency wants to show that it performed due diligence surrounding the change, he said, citing criticism from the generic drug industry and members of Congress.
Republican and Democratic lawmakers questioned whether the agency had the authority to make the change. A collection of 28 House and Senate lawmakers wrote to Commissioner Margaret Hamburg asking her to justify the agency’s authority.
During a House committee hearing last year, Republican lawmakers blasted agency officials for consulting with trial attorneys but not the generic drug industry when drafting the rule. The agency denied it kept industry in the dark.
Democratic lawmakers also had doubts. Rep. Steve Israel, D-N.Y., and then-Rep. Timothy Bishop, D-N.Y., wrote Hamburg last August concerned about creating confusion for doctors.
As opposed to a branded drug, which is usually manufactured by just one company, multiple companies could make their own version of a generic drug. Patients and doctors could get confused if there are multiple labels for the same medicine, which could occur if one generic manufacturer updates the labeling for its product but the others don’t, the lawmakers wrote.
The Generic Pharmaceutical Association vehemently opposed the regulation, even commissioning a study last year that claimed it would add $400 billion in healthcare costs a year because generic makers will have to fight liability lawsuits. The association is concerned generic drug makers could be taken to court if they don’t update safety labeling fast enough.
Such lawsuits have occurred before. In fact, the Supreme Court declined to hear such a case earlier this year. Teva Pharmaceuticals appealed to the court to overturn a lower court’s ruling that found it liable for failing to quickly warn doctors of safety problems with the company’s generic version of Merck’s osteoporosis drug Fosamax.
