Big Pharma must get its fingers out of the FDA



Pat Sikora

Since the summer of 2018, the FDA has listed over 10 heart medications that have been voluntarily recalled due to traces of N-Nitrosodimethylamine. Listed as a possible carcinogen by the World Health Organization, NDMA is a component of rocket fuel as well as a contaminant of certain pesticides. While it is obvious that components of rocket fuel should never be mixed in with medication, the compound is much more prevalent than one would expect. So much so that the Food and Drug Administration has also issued a warning regarding the shortage of these blood pressure medications as a result of all the recalls, according to NBC News.

While it is still not certain what has caused the massive contamination of these products, many have been linked to a Chinese manufacturer, Zhejiang Huahai Pharmaceutical Co., Ltd. The company has been cited and warned of its manufacturing violations and has even been placed on the FDA’s import alert list. While the import alert does not allow any finished products from ZHP to enter the United States. , CNBC states that European health regulators claim the traces were most likely caused by a production change in 2012.

Six years is a long time to pollute the marketplace and more recalls over NDMA are expected to continue. Clearly the precautions currently taken by pharmaceutical companies are not enough, This raises the question of who exactly is responsible for making sure that patients are not exposed to rocket fuel ingredients. Though one would hope that pharmaceutical companies would put the health of their consumers above all else, corporations’ responsibilities are to their shareholders and not their patients. That is the crux of the issue and it seems unlikely that corporate values will change anytime soon.

This leads to the finger being pointed at the regulators. The FDA is responsible for protecting public health but has consistently allowed corporations to make profits at the expense of our health. According to the FDA, Torrent Pharmaceuticals Ltd. is listed four separate times for recalls linked to NDMA since June 2018. The proper precaution is to force a recall of all their products at once until it can be ensured that there are no more rocket fuel ingredients in them. Yet the FDA has not done so, instead relying on the voluntary recall of these products by the corporations based on their recommendations. The FDA rarely forces the recall of any product since it has received the power to do so in 2011.

The reason that the FDA appears to be ineffective is due to a systemic issue. There has been a massive conflict of interest since the FDA had stopped being completely funded by taxpayer dollars in 1992 via the Prescription Drug User Fee Act. The PDUFA allowed for the FDA to collect fees from pharmaceutical companies for the approval of new drugs. Not only did this speed up the drug approval process, it also allowed for the FDA to have a profitable relationship with the drug companies. That means that the people who are supposed to be regulating the drug companies are now funded by the drug companies.

Since we’ve legalized a massive conflict of interest, it is no surprise that the FDA has not been effectively doing its job. Speeding up the new drug approval process and often times looking the other way on harmful products are just some of the ways this corruption has made the FDA untrustworthy, making many skeptical of modern medicine — another example of why money needs to get out of politics. The only way to make the FDA objective and independent is to get Big Pharma out of the funding process. The FDA needs to be revamped and fully funded with tax dollars with a new independent body who will actually look out for the American people.