The company released a statement to Reuters Health saying recruitment was slow because multiple sclerosis therapy has evolved. Results of the study are expected in the second half of next year.
One example cited by the researchers is being challenged. The case involves Victoza, Novo Nordisk’s widely prescribed drug for type 2 diabetes. Animal tests showed it might cause thyroid cancer. The FDA ordered the company to create a 15-year registry to record cases of thyroid cancer among users. The deadline for submitting rules for running the registry was July 2010.
The Woloshin team contends that no protocol for the registry has been submitted and cites an FDA website showing the registry as “Delayed.”
But company spokesman Ken Inchausti supplied a link to the trial on the website clinicaltrials.gov showing that enrollment began in January 2012. He told Reuters Health in an email that 996 patients have been interviewed to date.
Woloshin and colleagues write that their data show 16% of the ongoing studies are on schedule.
“Although being on schedule is reassuring, we would argue that some FDA-specified schedules are too long,” they write. The team believes the FDA should set shorter deadlines and impose penalties when companies miss these deadlines.
“For example,” they write, “the schedule for a 1-year pediatric safety and efficacy study for Welchol (colesevelam), used to assess treatment effects on type 2 diabetes in children . . . allowed 6 years for completion; an additional 4-year extension was also granted.”
The drug is marketed in the U.S. by Daiichi Sankyo, Japan’s second largest pharmaceutical company.
In some cases, the FDA has simply dropped a requirement for a postapproval study without giving a reason. “Adding this information to its public postapproval database would increase transparency,” Woloshin’s team writes.
The FDA statement does not directly respond to the suggestions. “Over time, advances in science, changes in standards of care, and new clinical information can affect study feasibility, design requirements, and even the need for or the appropriateness of a study,” the agency said.
“The FDA tracks these circumstances carefully and works with manufacturers to ensure that the postmarketing requirement or commitment study provides the information needed for public health,” it added.
Reference
- Woloshin S, Schwartz LM, White B, et al. The Fate of FDA Postapproval Studies. New England Journal of Medicine. 2017 Sep 21;377(12):1114-1117.
