The pharmacy companies that operate over-the-counter drugs that are being tested for the use in humans have decided to close their doors for the day on Feb 1, the FDA said Friday.
The move is the latest move by the drug industry to avoid the federal government’s deadline for testing and labeling of new drugs that the agency says could cause a surge in deaths in humans.
The moves by the pharmaceutical industry come after the Food and Drug Administration delayed testing and marketing of the drugs, known as erythropoietin-releasing factor-A inhibitors (EPI-rs), in February for one year after the agency issued an interim regulation requiring that they be tested and labeled.
The FDA last month also delayed testing of the erythrocyte membrane lipase inhibitors (ELM) epigallocatechin gallate-3 (EGCG-3) and erythromycin-resistance-associated drugs (ER-ARS), a drug that has been on the market since 1999, until the end of February.
The drug industry is fighting the delay by claiming that the FDA did not require them to comply with the interim regulation.
The drug companies say they are not going to be able to fulfill the testing requirement, and that it will take months for the FDA to enforce the rule.
“We have received assurances from the FDA that we will be able meet the December 3 deadline for compliance, but the FDA has not made this clear in the interim regulations and the interim rules are only a placeholder until the FDA is ready to enforce them,” said Michael J. Pfleger, president of the Pharmaceutical Research and Manufacturers of America.
“We believe it’s imperative that the public be assured that there is no rush to enact the rule.”
In its December 31, 2017 interim regulation, the F.D.A. required that drugs be tested on a pre-specified schedule and that a final rule would be issued within 180 days.
The interim regulations did not specify when testing and manufacturing would end, but they did say that the drugs would have to be available by February.
“There is a reason for this delay: We cannot meet the October 1 deadline,” the interim rule states.
“The interim rules do not require drug manufacturers to comply immediately.
They do not specify a date by which these products must be available for testing.”
But on Feb 5, the interim FDA said it would issue a final interim rule, which will provide for additional time for the companies to comply.
The final rule will include additional testing requirements and require drug makers to produce their drugs in bulk, as well as more stringent reporting requirements.
“It is critical that the government continue to protect the safety of consumers and ensure that these drugs are being used safely and effectively,” the FDA wrote in a blog post announcing the delay.
“In the meantime, FDA and the industry will work with the Department of Health and Human Services to ensure that all FDA approved drugs are available for public use as quickly as possible.”FDA spokesman Tom Harkin said the agency is reviewing the decision to keep the door closed.
“The interim FDA rule has not yet been finalized and the final rule is still pending.
The agency is working with the manufacturers to make the necessary changes,” he said.
“As the FDA moves forward, we will continue to work with our partners in the drug development industry and others to make sure FDA rules are implemented quickly.”
The interim rule also requires drug companies to notify the public of their decision to not comply with FDA rules.
FDA said in its blog post that it has notified drug manufacturers that they will have to comply by Feb. 10.
“At that time, the companies will be required to provide information to the FDA on the date they will cease compliance with the rule and the specific steps they will take to comply,” the blog post said.
The decision to close pharmacies comes on the heels of a similar announcement from the drug companies in February that they would not meet the February 31 deadline.
In a blog posting on Feb 4, Johnson & Johnson, Pfizer and AbbVie said they will no longer be testing the drugs in humans until the interim F.E.A.’s interim regulation is finalized.
“While we have not received a letter from the FASC yet, we have received a formal letter from FDA, and we have been assured that they are working toward a timeline for the final F.B.I. regulation to be issued,” the companies said in the blog posting.
“Given the uncertainty in the FDA’s approach to the interim testing requirements, we are now preparing to move forward and comply with F.H.S. and FDA guidance as quickly and as completely as possible.
We will do this regardless of the timeline for issuing the final regulation.”
In an interview with The Associated Press in February, Pflegg, the executive vice president of public affairs at the pharmaceutical company, said the delay was an “important milestone” for the drug