When it comes to drug shortages, the FDA says it is not the problem. It is part of the solution.
That is what the agency says in a 9-page letter, with point-by-point refutations, to the ranking member of a House committee that last month issued a report pinning the blame for drug shortages on what it called overly zealous enforcement by the FDA.
Yes, manufacturing issues led to many of the shortages. Yes, in many cases the FDA had issued warning letters to the companies about those issues. But essentially, the agency says, the plant problems needed to be fixed because the public was at risk. Problems included contaminated drugs, cartridges containing too much morphine and injectable drugs that contained glass or metal particles that could injure patients who received them. In each case, the companies involved closed their plants voluntarily to fix the issues, even when the agency looked for ways to allow production to continue, the letter says.
The letter addresses a report, issued last month by the Committee on Oversight and Government Reform, that questioned the FDA's actions, which led four of the largest generic drugmakers to halt some production of sometimes critical drugs that are now in short supply. The report points out that drugmakers--Hospira ($HSP), Teva Pharmaceutical Industries ($TEVA), Sandoz, the generics division of Novartis ($NVS), and Boehringer Ingelheim's Bedford Laboratories--lost 30% of their capacity when the FDA expected them to upgrade their manufacturing.
Of the 219 drugs on the shortage list when the report was issued, it says 128--or 58%--were produced by those facilities. The report, however, was viewed as deeply political since it was issued during the presidential campaign and suggested that the agency has become too hard on drugmakers since the appointment by President Obama of Margaret Hamburg as FDA commissioner.
Still, concern and frustration over continuing shortages have stirred up the public and healthcare providers as well as politicians who hear from constituents who face the prospect of death because the best treatments are unavailable. The American Society of Clinical Oncology in June, for example, called for fines against drugmakers that don't give the FDA an early heads-up if they face anything that might lead to a shortage.
The FDA in its response to questions about why the agency issued warning letters against the four genericsmakers gives a company-by-company explanation of problems at plants that led to the shutdown. It counters the House report contention that there were no reports of patients being harmed by any of the drugs that were affected by the remediation. While the number of warning letters issued rose from 30 in 2008 to 60 in 2010 and 48 in 2011, the FDA says it did not increase "radically" as the report suggests. "They are not the root cause of the recent increase in drug shortages." Additionally, the FDA says by getting earlier notification from drugmakers about events that might lead to shortages and working cooperatively with them, the agency was able to avoid 195 shortages in 2011 and 90 so far this year.
The FDA says it is very concerned with drug shortages and putting a lot of time and attention toward avoiding shortages and addressing them when they happen. "FDA alone cannot solve the drug shortages crisis." It says the long-term solution is going to require drugmakers to make the investments in infrastructure so that they can produce drugs that don't pose threats to the public.
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