Senate Harshly Criticizes the FDA
The day after the November 2012 House hearing, where the FDA asked for more authority, a bi-partisan staff of the Senate Health, Education, Labor, and Pensions Committee issued a report detailing how federal and state regulators knew nearly a decade before of serious safety concerns with the pharmacy (NECC) tied to hundreds of meningitis cases, but failed to act decisively. The report concluded that “ bureaucratic inertia appears to be what allowed a bad actor to repeatedly risk public health.”19,20
While acknowledging the lack of clarity in what the FDA’s role should be in regulating compounding pharmacies , the Senate cited plenty of evidence that the FDA should have taken action against NECC, which clearly was functioning as a drug factory.
The Senate investigators wrote, “Both federal and state regulators were well aware that NECC and its owners posed a risk to the public health” and “repeatedly failed to demonstrate that the company could safely compound sterile products.”19
The Senate report uncovered an internal FDA memo in 2003 that concluded there was “potential for serious public health consequences if NECC’s compounding practices, in particular those relating to specific sterile products, are not improved .”19
The Senate confirmed that methylprednisolone produced by NECC “ had previously been a suspected cause of at least two cases with bacterial meningitis-like symptoms” in 2002, leading to an FDA inspection…with no meaningful action taken.19
Most Senators expressed skepticism the FDA could effectively use widened authority under any new law, one stating “the FDA has failed to use its existing authority…” with another stating, “This has been going on since 2002…It took all this time, and nobody did anything.”20
Regrettably, some Senators still believe that giving the FDA more tax dollars will solve these issues of bureaucratic incompetence and mismanagement.
At the Senate hearing, FDA Commissioner Margaret A. Hamburg conceded:
“Perhaps we should have been more aggressive,” referring to the FDA’s failure to inspect NECC and follow up on the 2006 warning letter. “There was a lot of debate within the agency about whether to proceed.”20
Senators repeatedly questioned the FDA’s sending NECC a warning letter in 2006 and a letter in 2008 saying that it planned to inspect, but not following through until after the fungal meningitis outbreak occurred in late 2012.19,21
CBS News Enables FDA to Temporarily Deceive Public
On March 10, 2013, CBS News’ 60 Minutes aired an emotional broadcast about the NECC tragedy that included interviewing victims who suffered horrific illnesses, along with family members of those who died.22
60 Minutes accurately told this story about NECC-contaminated drugs that caused 58 deaths and over 700 serious illnesses.1
What 60 Minutes omitted was the fact that the FDA knew about this disaster-waiting-to-happen, but failed to stop it until Americans started dying in 2012.
FDA officials were given free rein on 60 Minutes to blame this catastrophe on a lack of regulatory authority. As you’re learning here, the fault instead lies with bureaucratic ineptitude at the hands of the FDA and the state pharmacy board that permitted these lethal deviations in good manufacturing practices to occur.
Instead of blaming the FDA for ignoring this lethal problem, CBS News let FDA officials blame Congress for not giving the FDA more regulatory power.
What the FDA does not want the public to know is that the reason this shady manufacturer was able to take over such a significant part of the market is that FDA actions caused other companies to stop making certain injectable drugs.
CBS News overlooked the House and Senate investigations that documented FDA’s egregious failings in the NECC matter.
Congress Strikes Back at the FDA
On April 16, 2013, the FDA was subpoenaed to appear before Congress to account for why more wasn’t done to protect the public against contaminated drugs made at NECC.13,23
Congress wanted the FDA Commissioner to explain why she was not more forthcoming about the FDA failures during the House and Senate hearings held in November 2012.
According to the House Committee report on the NECC debacle:
- “The investigation revealed what FDA Commissioner Margaret Hamburg did not disclose during the November 2012 hearing: FDA received a litany of complaints about NECC and its sister company, Ameridose, right up until the 2012 outbreak.”13
- “These complaints were related to the safety and potency of NECC and Ameridose products, issues that the FDA failed to routinely, if ever, inform the state about.”13
- “After reviewing more than 27,000 documents, we found a dramatically different picture than the one painted by the FDA during our initial hearing in November. We now know that doctors, patients, providers, and whistleblowers tried to warn FDA for years that NECC and Ameridose were operating as manufacturers and marketing their products nationwide without patient prescriptions.”13
- “The FDA was also warned about sterility and safety issues with the companies’ products. Rather than do its job and protect the patients who were taking NECC and Ameridose drugs, FDA chose not to act.”13
The box below contains highlights from the House Committee report showing that FDA failures contributed to the NECC disaster and how the FDA tried to cover up their own ineptitudes.
What Congress Overlooked
What was not discussed in Congressional hearings was the FDA’s history of abusing and misusing whatever authority Congress gave it.
For example, when the FDA first discovered problems at NECC (in 2002), it chose to direct its resources to prosecuting a man named Jay Kimball, who sold a drug (liquid deprenyl) that harmed no one. Jay Kimball remains in prison.24
In 2006, while the FDA did not think it needed to stop NECC’s lethal manufacturing practices, it somehow found the time to censor claims by cherry growers that cited scientific studies on their website showing cherries conferred health benefits.25
What few understand is how the FDA has historically abused its authority in a discriminatory manner. The new “authority” the FDA is seeking would enable the agency to pick out small, well-run pharmaceutical firms and regulate them out of business using minor technical arguments that have no bearing on safety.
GLAXO Pays $750 Million Fine for Quality Lapses
GlaxoSmithKline is the world’s 4th largest drug maker, with annual sales of nearly $46 billion and profits of almost $9 billion.26
In July 2002, the FDA sent a warning letter about quality problems uncovered at one of GLAXO’s subsidiary manufacturers. The egregious problems, however, were not corrected despite additional FDA inspections that continued to turn up severe problems, including failure to safeguard against microbial contamination.27
The FDA initiated a seizure action in 2005 to remove adulterated and improperly made drugs.28
Horrendous problems persisted, however, until the Justice Department filed a criminal complaint against GlaxoSmithKline and stopped what could have been a human catastrophe.29
In October 2010, GlaxoSmithKline agreed to plead guilty and pay a $750 million fine to resolve criminal and civil liability regarding the manufacturing deficiencies.29
Glaxo’s Defective Drugs
The defective drugs, manufactured between 2001 and 2005, were Kytril, Bactroban, Paxil CR, and Avandamet.29
Kytril is a sterile injectable anti-nausea medication used by cancer patients receiving chemotherapy or radiation. Bactroban is a topical anti-infection ointment used to treat skin infections. Paxil CR is the controlled-release formulation of the popular anti-depressant drug Paxil, and Avandamet is a combination of Avandia and metformin.
Avandia has since essentially disappeared from the market because of increased heart attack risks, though an FDA advisory panel recently recommended it be allowed to be prescribed to certain diabetic patients.30
Years after FDA approval, Glaxo sent out a black box warning about increased suicide risks in users of Paxil.31
With the realization that cardiovascular disease is the leading cause of death amongst diabetics, and suicide a huge risk in depressed patients, the notion that the FDA approved drugs with these kinds of side effects borders on absurdity.32,33 These lethal side effect issues, however, are irrelevant to the manufacturing lapses that occurred.
According to an employee who filed a lawsuit against Glaxo over these uncorrected defects, the water system was contaminated, the air system allowed for cross-contamination between products, the warehouse was so overcrowded that rented vans were used for storage, the plant could not ensure the sterility of intravenous drugs, and pills of differing strengths were sometimes mixed in the same bottles.34 Although FDA inspectors had spotted some problems, most were missed.
Glaxo paid the $750 million fine and admitted that its subsidiary failed to ensure that Kytril and Bactroban finished products were free of contamination from microorganisms. It also admitted that its manufacturing process caused Paxil CR two-layer tablets to split, which the company itself called a “critical defect,” because potential distribution of tablets would not have any therapeutic effect and no controlled release mechanism. 35
Glaxo admitted that Avandamet tablets did not always have the proper mix of active ingredients and, as a result, potentially contained too much or too little of the ingredient with the therapeutic effect.29