In a blow to the integrity of the U.S. Food and Drug Administration (FDA), a one-time inspector raised concerns about the agency’s recent and sweeping blood pressure medication recall. The former inspector, Massoud Motamed, suggests the FDA does not have the capacity to effectively monitor imported pharmaceuticals and that this shortcoming is risking consumer safety.
Massoud Motamed: Blood Pressure Medication Recall Should Have Been Sooner
Massoud Motamed is a Texas native who worked for the FDA for three years as an investigator. His job was mainly working overseas inspecting foreign pharmaceutical manufacturing facilities. Motamed had been working as an FDA inspector for two years when the agency assigned him to inspect the Zhejiang Huahai Pharmaceutical Plant in Linhai, China.
After a four-day inspection, he left the facility with grave concerns, which were fully disclosed in his reports. His concerns included:
- Facilities and equipment in poor repair
- Anomalies in testing that went without investigation
- Unknown impurities dismissed by the facility as laboratory error
The facility he inspected was the very same as the first to issue a blood pressure medication recall in May 2017 for the presence of impurities that are probable human carcinogens.
Though his misgivings were initially enough for the FDA to issue a warning letter to the Chinese company, within three months officials at the agency reversed the warning and allowed Zhejiang to fix the problems Motamed identified on a voluntary basis.
When the FDA initially announced the first valsartan recalls, Motamed was not surprised. After all, he had issued an official warning to the manufacturer more than a year before. Motamed left the FDA in 2017.
Reliance on Foreign Manufacturers
The problems in the Chinese facility are hardly unique. According to Motamed, the blood pressure medication recall only calls attention to the larger problem – American consumers have increasingly come to rely on foreign manufacturers for their pharmaceutical products. About 85 percent of facilities that supply American markets with raw ingredients for pharmaceuticals are foreign. Many of these are in India or China where production costs are much lower than they are here.
Some, including Motamed, suggest the shift to the reliance on foreign facilities has contributed to a slew of recent recalls, including the recent blood pressure medication recall. Others say dependence on foreign producers make it harder to trust the safety of medications we consume in the United States.
The Waves of Valsartan Recalls
Since May 2017, drug manufacturers have announced recalls of more than half of the supply of blood pressure medication available to consumers. In multiple announcements, the FDA eventually initiated a total of 45 blood pressure medication recalls. The recalls apply to generic life-saving blood pressure medications known as:
All these drugs have raw ingredients that the FDA has traced back to foreign pharmaceutical plants. It seems American drug manufacturers are getting what they paid for. The lure of overseas producers is their significantly lower cost. The lower cost has come at the price of lower quality.
Are Foreign Manufacturers Impossible to Inspect?
Motamed further suggests that inspecting foreign facilities is the whole and the sum of the issue. The blood pressure medication recalls represent only symptoms that will keep happening until the systemic problem of foreign drug makers being able to conceal problems from the FDA is resolved.
The FDA only inspects about one in five foreign registered pharmaceutical manufacturing facilities every year. Language and custom barriers also mean the agency relies on the word of the manufacturers themselves more than should be allowed by a federal regulatory agency.
FDA investigators can’t show up at a foreign facility unannounced the way they can in the U.S. Travel restrictions sometimes mean inspectors have to leave the country before they can complete an inspection as thoroughly as they would have on American soil.
Some foreign facilities seem even brazen about flouting the authority of the FDA. Motamed reported that he once investigated a manufacturer in India who shredded documents for four solid days prior to his arrival. Noticing suspicious activity in the record-keeping rooms, he watched the facility’s security tapes. Destruction of evidence on this scale can only mean systemic issues at the plant that could endanger lives.
Though the FDA did cite the company, Hetero, for that incident, problems clearly continue. Hetero was one of the sources of contaminated medicine in the recent valsartan recalls. The incident with destroying the evidence before the inspector could see it took place 19 months before the blood pressure medication recalls were announced.
The Scope of Blood Pressure Medication Recalls and Who Might be Affected
The ongoing blood pressure medication recall has caused a nationwide shortage of angiotensin II receptor blockers (ARBs). These are medications that work by relaxing and widening blood vessels to lower blood pressure. In 2016, 1.6 million people filled prescriptions for valsartan, and another 9.2 million filled losartan prescriptions.
There is no way to know how many people have been exposed to probable carcinogens while taking these medications. The tainted drugs were on the market for four years before the FDA recalled them. Dozens of victims are already taking part in a multidistrict litigation (MDL) in pursuit of damages for the harm they suffered while taking tainted medications.
Regardless, ARBs are so essential to the patients who need them that the FDA actually suggested patients continue to take the carcinogen-tainted drugs because it would be safer than stopping all together. The agency expects the national supply of these frequently prescribed medications to bounce back to normal levels in about six months.
Have Questions about the Blood Pressure Medication Recall?
At Drug and Device Watch, we have been watching and reporting on this developing story for months. The blood pressure medication recalls have impacted millions of people. If you have questions or concerns about these or other recalled medications, contact us to learn more.
If you or someone you love has been diagnosed with cancer after taking ARBs, Drug and Device Watch wants to speak with you. You may have a claim. Call 1-888-458-6825 now to get started with a free consultation. You can also email us and we will get in touch with you as soon as possible.