As officials from the United States Food and Drug Administration (FDA) admitted recently they have seen an upsurge in the number of pharmaceuticals that have been linked to contamination and impurities, the developments have forced the agency to reexamine its regulations regarding drug safety.
In most cases, the problems appear to stem from a combination of poor management oversight, lack of quality control, and discrepancies in manufacturing standards. With many U.S. generic drugs using ingredients from China and India, federal regulators have discovered numerous instances where officials in these and other nations have destroyed or hidden testing data which revealed quality control failures. Instead, officials made the data to show passing results in quality control, ultimately putting patients at risk. Because of this, FDA officials want to impose stricter regulations on drug manufacturers in an effort to require adequate testing needed to ensure the safety of pills given to patients.
According to FDA officials and federal health experts, much of the problem stems from having an increasing number of generic drugs and drug ingredients being made in nations such as China and India, both of which have far less stringent quality control standards than the United States. As a result, the drug industry currently relies on manufacturers in these countries to regulate themselves, which many experts point to as being the most significant problem.
Based on interviews with FDA officials, most expect any changes that are made will take at a minimum several years to implement. Meantime, numerous U.S. companies have had to recall various cardiovascular and other drugs for fear they may contain several different carcinogens.
Due to labor costs being much lower in countries such as China and India, along with fewer regulations, more and more U.S. drug manufacturers have been choosing to outsource their drug manufacturing in recent years. As a result, while drug companies are not required to disclose where they purchase active ingredients for their medicines, the FDA estimate more than 80 percent of these ingredients come from outside the United States.
While outsourcing in this area has increased dramatically in recent years, so too has the number of production issues related to active ingredients. According to the FDA, it has issued 282 warning letters to companies since 2015, with more than 25% of those letters referencing problems concerning active ingredients. An example of this involves letters sent to well-known drug manufacturer Pfizer, which cited problems at the company’s site in Tamil Nadu, India. Stating the facility failed to report accurate quality results regarding ingredients, the FDA eventually chose to ban the facility from sending drugs into the United States.
Though it may sound as if all the blame is to be placed on drug manufacturing facilities outside the United States, members of the Congressional House Energy and Commerce Committee point to a steep decline in the number of surveillance inspections conducted by the FDA and its U.S. inspectors in recent years. According to the latest data, in 2018 the number of inspections performed fell by more than 11 percent. While FDA administrators have defended the agency’s approach to inspections, many lawmakers and industry experts believe the agency has come to rely too much on companies self-regulating themselves.
As a much greater emphasis on data integrity is currently underway in the FDA regarding this issue, some wonder just how much things will change. With many whistleblowers in the industry noting employees in foreign companies are routinely caught deleting computer files, destroying or altering documents, and lying to inspectors about manufacturing processes and standards, health experts feel U.S. patients will continue to be put at risk.
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