On Nov. 20, the Food and Drug Administration (FDA) of the Ministry of Health and Welfare ordered the recall of all 80mg and 160mg Prevan film-coated tablets — medication for high blood pressure produced by Genovate Biotechnology Co (健亞生物科技) — after the drug was found to contain a carcinogenic chemical.
As there have been three recalls of blood pressure medication in only a few months, questions need to be asked about what is wrong with the quality control of imported pharmaceutical ingredients, and what else the FDA should do in addition to ordering recalls?
In the past, finding raw material supply sources and quality control were mostly the responsibility of pharmaceutical companies, which self-managed in accordance with the Good Manufacturing Practice (GMP) standard.
Although GMP is in common use internationally, raw material safety issues occur often. As a result, all countries have been re-evaluating and improving source review and inspection management to ensure the safety of medication.
There are some feasible actions that the FDA could take. In terms of post-approval inspection, it could integrate written and on-the-spot inspections to implement risk management at pharmaceutical companies and factories, and ensure that the medication production information is identical to the registered information.
For high-risk items, it could plan for inspectors to verify whether the product documents are in line with the documents issued following the original inspection.
Also, during factory inspections, the FDA could conduct random sample testing and improve the inspection of supplier approval and supervision in accordance with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and GMP to maintain product quality and safety.
In addition to regular factory inspections, extra factory checks could be conducted in response to special incidents, such as when a company is being reported, a marketed product fails a quality test, a defective product is reported or if there has been a related news report.
To ensure the quality of products on the market, the FDA could conduct theme-based inspections and send inspectors to collect samples directly from factories, so as to monitor quality. If a product fails a test, the FDA should order the company to recall the drug.
Despite the FDA’s recall demand, it is reported that local health bureaus nationwide do not have sufficient personnel to conduct inspections.
Perhaps the FDA could demand that local hospitals, clinics and pharmacies remove the products from their shelves by promptly passing the information to them through its penalty mechanism. Patients who are taking the defective drug could ask doctors to replace it with similar high blood pressure medication.
Despite the series of high blood pressure drug recalls in recent months, it seems as if the FDA is merely being reactionary, fixing holes after they are discovered.
What could it do to tighten the quality control of imported pharmaceutical ingredients? Should it not look into where the responsibility lies if strict inspections are not carried out on raw material imports?
A government that only demands recalls, but does not review the handling of a case, look into accountability or demand compensation from the medical companies involved, can hardly be said to be responsible.
Liu Dian-ke is a pharmacist and a doctoral student of business administration at National Chung Cheng University.
Translated by Eddy Chang
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