Drugmakers agree to clean up plants, take other steps to fight antibiotic resistance

Print 26 September 2016
Eric Palmer / Fierce Pharma

More than a dozen pharmaceutical companies from Big Pharma players to CMOs have agreed to take steps to fight antibiotic resistance, including reviewing their manufacturing and supply chains and working on standards for cleaning up antibiotic waste discharge.

The agreement was announced this week as part of a United Nations meeting in New York where antibiotic resistance was said to be one of the pressing issues facing the world. It is a pharma specific follow-up to the broader Davos Declaration signed by about 100 companies during meetings early this year in Switzerland.

Those signing on are Allergan, Cipla, DSM, Sinochem Pharmaceuticals, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Pfizer, Roche, Ulrike Engels-Lange, Sanofi, Shionogi and Wockhardt.

Three other steps the 13 drug companies agreed to take are to help ensure antibiotics are used only by patients who need them; to improve access to current and future antibiotics, vaccines, and diagnostics while working to reduce the prevalence of substandard and counterfeit antibiotics in high-risk markets; and to look for places to cooperate in developing new antibiotics.

While companies like Pfizer and GSK were unable to provide specific steps they will take toward the agreement, the drugmakers said they are committed.

Though the commitment may be there, history has shown this to be a tough issue with which to deal. The FDA's effort to push animal producers away from indiscriminate use of antibiotics in production animals is one prime example. In December 2013, manufacturers of 293 products were warned by the FDA that they would have to revise the labels of their animal antibiotics by the end of this year. In January, mandatory rules instituted by the FDA will prohibit companies from selling antibiotics for non-medical uses like promoting growth, and they will require farmers who want to use antibiotics in their animals to get the drugs from veterinarians. But a recent FDA report indicated that effort is not going well, with only one label having been revised so far.

Still, some animal drugmakers like Eli Lilly and Merck are working on getting animal producers to move to using vaccines instead of antibiotics, a shift that could be good for their bottom lines as well as for the effort to fight antibiotic resistance.

There also is a big problem in parts of the world, like India and Asia, where companies have been found selling substandard antibiotics which can lead to resistance. India produces about 40% of the antibiotics used in the world, and some Indian drugmakers have been found by the World Health Organization to be selling substandard drugs. But it has been a difficult problem for the WHO to uncover and monitor.  

Drugmakers agreed to clean up their plants and processes as part of the effort and there have been indications in FDA warning letters that some antibiotic manufacturing plants have had lax processes. In these cases, the FDA is looking at cross contamination and the potential for fatal allergic reactions, not antibiotic resistance, but they have found that some antibiotic facilities are in need of serious upgrades.

In one Big Pharma example recently, the FDA in July issued a particularly stern warning letter to a GSK antibiotics plant in England, noting 187 instances of penicillin in nonpenicillin manufacturing areas in 3.5 years.

The agency said GSK needed to take significant steps to clean up its operation there. The FDA laid out two options for GSK, saying it needs to either dedicate the facility to penicillin API production alone so that cross-contamination will not be an issue, or submit a plan for fully decontaminating the API facility, something it warned up front is extremely difficult so will have to meet high expectations from the agency.

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