An essay highlights US drug safety issues in drug preparation pharmacies

BOSTON (Reuters) – A top US Food and Drug Administration official said on Monday that the agency was worried about drugs made by pharmacies and that it continued to experience problems six years after a outbreak of fungal meningitis linked to a pharmacy in Massachusetts, killing 76 people.

Janet Woodcock, who heads the FDA's pharmaceuticals division, told a federal court in Boston that she had never witnessed an outbreak similar to that caused in 2012 by the mold-contaminated steroids of the New England Compounding. Center.

Mixed drugstores make custom medicines for patients whose needs can not be met by FDA approved drugs.

Woodcock's testimony took place during the sixth week of the trial of six former employees or NECC executives indicted after the outbreak. Prosecutors said the defendants had misled hospitals about the quality of NECC's medicines and the regulators about how it works.

The six are Gregory Conigliaro, a co-owner; Sharon Carter, former NECC Operations Director; and pharmacists Gene Svirskiy, Christopher Leary, Joseph Evanosky and Alla Stepanets. They pleaded not guilty.

Woodcock said that although the epidemic involving NECC, now gone, is the worst it has ever seen with drugs manufactured by drugstores, it continues to be a problem.

"We still see patient issues related to this now," said Woodcock.

The comment highlighted what the authorities claim to be persistent failures identified in drug preparation pharmacies.

According to the FDA, in more than 500 inspections of such pharmacies since the epidemic, unhealthy conditions, including dead insects and microbial growth, have often been discovered.

According to the Pew Charitable Trusts, a nonprofit organization of public interest, 1,416 people from 2011 to 2017 experienced adverse effects after taking compound drugs that presented potential or actual problems, such as contamination or an excess of power. Of these, 115 died.

"I think we've come a long way since NECC, but I think there is still a lot of work to be done to improve the quality of compound drugs," Julie Dohm, FDA's senior science advisor, told Reuters. formulation,

Traditionally, pharmacies have formulated compound drugs to meet a patient's needs, such as an allergy to an ingredient in an FDA-approved drug.

At the time of the outbreak, however, some state-regulated food preparation pharmacies had become large companies that delivered large volumes of drugs to hospitals.

These companies include NECC, whose owners and employees save money and make drugs in unsanitary conditions, prosecutors said.

Fourteen people linked to NECC were subsequently charged, including the six currently on trial.

NECC co-founder Barry Cadden and former supervising pharmacist Glenn Chin have been convicted of racketeering and fraud in two previous trials. They serve respectively nine and eight years in prison.

During his testimony Monday, Woodcock stated that NECC was a drug manufacturer posing as a state-regulated pharmacy that filled prescriptions for specific patients.

Following the outbreak of 2012, the 2013 Congress passed legislation establishing "outsourcing facilities" that can sell bulk products in bulk but must register with the FDA and comply with federal manufacturing standards.

But today, while there are thousands of prep pharmacies, the FDA lists only 70 registered outsourcing facilities, a level below what Dohm had planned. The FDA is now looking to make it easier for compaction companies to outsource.