[Editor’s Note: This article originally appeared on The Pharma Compliance Blog. Permission to republish has been granted by CIS.]
One responsibility of the Federal Food & Drug Administration (FDA) is protecting the public health by assuring the safety, efficacy, and security of human drug products. In order to continue protecting the public, the FDA is asking Congress for greater authority to inspect foreign drug manufactures and the ability to mandate drug products recalls.
Last month during a hearing with the United States Senate committee, expert Deborah Autor, the FDA’s deputy commissioner for global regulatory operations and policy, expressed concern about the potential for drug contamination and counterfeiting from foreign manufacturers. Autor stated that another crisis is “not a matter of if, it’s a matter of when.”
The request comes as a result of increased outsourcing of manufacturing processes by many pharmaceutical companies. The increase in outsourcing has created a greater number of manufacturing sites to be inspected. With the FDA having limited staffing, it has become increasingly difficult to complete inspections in a reasonable amount of time. As noted in a previous blog post, "FDA, EMA, TGA Collaboration," some regulatory agencies in the US, Europe and Australia have taken steps to address the global issue by collaborating resources. However, the joint effort only applies to manufacturing sites of active pharmaceutical ingredients.
FDA Commissioner Margaret Hamburg stated that “forty percent of drugs Americans take are made outside the U.S. and 80 percent of active ingredients in pharmaceuticals come from beyond national borders.” China has the highest number of establishments in the FDA’s inventory at 920, followed by India, Canada and Germany.
With the FDA having limited resources to inspect all non US sites, they are asking Congress specifically for:
- The ability to refuse products at the border when a maker declines an inspection.
- The power to compel drug makers to recall risky medicines.
- The ability to request that drug makers institute a track-and-trace system that could follow treatments from manufacturer to shelf.
Will History Repeat?
In order to continue protecting the public’s safety, the FDA’s risk management programs must continue to evolve with the rapidly growing global pharmaceutical industry, but in a way that doesn’t hinder progress. Some government officials believe the FDA is trying to over-regulate the industry. Others have said that requiring a tracking system for small businesses would be unreasonable due to the cost involved. However, without these additional measures, history could likely repeat itself.
Taking a look back: 1961 (Germany) – thalidomide, a drug used to help reduce morning sickness in pregnant women, was found to be the cause of serious birth defects in thousands of children whose mothers used the drug during pregnancy. Most incidents occurred in Germany where the drug was not tested for efficacy. A smaller number of cases were found in the U.S. due to experimental use in clinical studies. Larger volumes of the drug were kept out of the U.S. with the help of Frances Oldham Kelsey, an FDA researcher, who refused to approve marketing of thalidomide in the U.S. due to poor safety information. As a result of this incident, the Kefauver-Harris Drug Amendments were established, as a part of the FD&C Act, to require drug manufacturers to prove that a drug is effective before use.
In recent years: 2008 (China) – a U.S. company manufactured and distributed a blood thinning medication, heparin, often used for dialysis treatments. After several deaths occurred with the use of this drug in 2007, an investigation was launched that determined that the raw materials imported from China were adulterated. The investigation discovered that changes to the raw materials were intentionally altered due to the lack of suitable raw materials and cost effectiveness. The product was pulled from the U.S. market after the FDA inspected the site and found numerous GMP violations.
Serious incidents such as these are the unfortunate result of ineffective risk management programs. Regulatory agencies, pharmaceutical companies and consumers need to make every effort to avoid serious adverse events from occurring. Although some fear over-regulating by the FDA, their request for more authority may be the steps needed to ensure the public’s safety.