Regulation of Pharmaceuticals in the USA

The pharmaceutical industry creates, finds, develops, and commercializes pharmaceuticals or drugs for the purpose to cure patients, administer them to others, cure them, mitigate their symptoms, or relieve their diseases. Pharmaceutical firms may engage in pure research or produce pharmaceutical products. Some of these products are known under different names like medicines, nutritional supplements, drugs and other drug products. Others are marketed under the names of vitamins, appetite suppressants, laxatives and inhalers.

Prescription drugs represent the major part of the pharmaceutical products. These products act as chemical substance used to cure a disease, aid in recovery from a disease, prevent recurrence of that disease, or prevent aggravation of that disease. Pharmaceuticals play a key role in providing patients with the symptom-based care they need, in ensuring the efficient administration of a patient’s medication, in judging the effectiveness of a drug, in monitoring the progress of a drug during treatment, and in identifying the effects of a drug on a patient’s health after treatment. Without prescription drugs, there would not be any practical use for antiviral drugs, blood pressure monitors, insulin, glucose or thyroid hormone medications.

A few years back, the FDA regulated the production of medicines and drug products. But the verdicts have changed a lot since then. The FDA can no longer control the manufacture of medicines unless they are approved by FDA for medical use. In addition, FDA cannot prohibit or regulate clinically proven effective new drug candidates. The manufacturers of branded prescription drugs are liable for any defect or error in the formulation of the medicine even after the medicines are FDA approved.

The FDA does not regulate or restrict the marketing of generic medicines. This means that generic drugs are not subject to the same conditions of quality assurance as those of original patented drugs. A case in point is the Covid-19 vaccine. An Italian research firm discovered that the combination of a gene-altering virus and a chemical found in L.A.S.A.P. caused a fatal vaccine related defect, resulting in death of healthy infants.

The legal division of the FDA has recently slapped a fine of $1.2 billion on the manufacturer of the L.A.S.A.P. vaccine, Kary Mullis. The fine was ordered by the U.S. Federal Court based on FDA’s power to control the manufacture, processing, distribution and retailing of pharmaceutical products. Kary Mullis, the president and co-founder of Kary M. and S.R.M. Orthopedics, faced criminal charges for his role in the vaccine scandal.

The FDA’s banning of Biogen Bioscience, the main developer of the Biogen Bioscience drug, from the U.S market will have serious repercussions on the pharmaceutical manufacturing industry in the USA. Biogen Bioscience was due to release a new line of medicines that overcome the diabetes complications. The Biogen Company, a unit of Kary Mullis and Syngenta plc, had signed an agreement with the Food and Drug Administration to develop the new product under licence from the German Company Humana. Biogen Bioscience lost the rights to its major product due to the FDA’s ban on Biogen Bioscience. The company’s main revenue generating drug, Trijicon, is facing competition from generic versions of the drug manufactured by other companies that are freely available in the market.

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