FDA strictly regulates diet pills

The United States, as the world’s largest obese country, has its Food and Drug Administration (hereinafter referred to as “FDA”) and is known as the “American health patron saint”. Its strict supervision of diet pills in the approval and circulation links, once in a period of up to 13 years, did not grant any new drugs for diet pills. Some of the experiences of his rock may be worthy of learning and learning from relevant Chinese institutions.

The First Obese Power: Crazy Diet Pills

There are 78 million obese people in the United States. According to a report made by the US Centers for Disease Control in May 2012, the proportion of obese people in the United States will increase from the current 34% to 42% by 2030.

This prompted many U.S. pharmaceutical companies to become the earliest manufacturers to start developing diet pills.

In the early 1980s, the United States has seen an upsurge in eating weight loss pills. Representative products are mainly fenfluramine, fenfluramine and dexfenfluramine, as well as some old weight-loss drugs such as phenytol, etc. These weight-loss drugs once swept the market, and their total sales were as high as US$800 million.

At this time, the regulatory requirements regarding the diet pill market have not been formed, and no sufficient clinical evidence has been given for the effect after taking the diet pills. Because the market is willing to accept this way of taking medications to solve the obesity problem, major pharmaceutical companies have once set their sights on the weight-loss drug market in order to obtain high profits.

However, just a few years later, medical experts found that frequent use of fenfluramine or dexfenfluramine may cause severe heart valve damage and eventually lead to ventricular dilatation and heart failure. In 1997, the United States FDA, which recognized the seriousness of the problem, first revoked the license to market for fenfluramine and subsequently revoked the license to dexfenfluramine.

Between 1997 and 2010, the FDA also ordered Fenfen, the star weight-loss compounding drug, to withdraw from the US market. The reason is that the main component of the drug is fenfluramine and phentermine, which may increase the risk of heart valve injury.

U.S. Wyeth Pharmaceuticals, which produces fenfluramine, has paid a heavy price. The company paid a total of up to 890 million U.S. dollars in medical expenses to compensate patients suffering from heart damage in the United States and Europe due to taking the company's production of fenfluramine (Phen-Phen).

Subsequently, the weight-loss drug market quickly fell to the bottom. Many diet pills were taken off the shelves and even banned from listing. For a time, pharmaceutical companies were very cautious about the intervention of this market.

The FDA declined to approve the Sanofi-Aventis company's Rimonabant listing. The drug is believed to cause mental depression and even increase suicidal tendencies. Both Merck and Pfizer subsequently abandoned the same type of drug development.

Subsequently, Abbott’s star diet pill Noemi Ting withdrew from the market because of the risk of increased heart attack and stroke.

Gatekeeper FDA: Strict Listing Process On June 27, 2012, the FDA approved for the first time in 13 years a new diet pill Belviq, followed by the approval of Qsymia diet pills developed by Vivus. This opening may be a sign that the diet pill market will usher in a new round of climax.

However, the FDA also advised patients to stop taking medication if they took Belviq for 12 weeks but failed to lose 5% of their body weight.

Since stopping the approval of new prescription diet pills in 1999, the FDA has sent a signal to pharmaceutical companies that money for diet pills is not profitable and that product safety is higher than market interest.

Not only that, the FDA also has a sound management process for the marketing of medicines including diet pills.

According to public information, FDA stipulates that if an enterprise's new drug is to be listed, it must pass the new drug forest farm trial IND, apply for FDA approval for the marketing of a new drug or generic drug, review the new drug review NDA or generic drug review ANDA, etc., and simultaneously meet the GMP requirements. In order to obtain "approved parts", organize production and sales. Within a few days after being approved, it is necessary to submit to FDA a list of all medicines produced and operated, and the FDA issues a drug registration number for each medicine.

The pharmaceutical companies in various countries, which are unwilling to give up, have issued their own weight-loss drug products to the FDA in hopes of conducting clinical trials of new weight-loss drugs.

In order to increase the threshold of clinical trials for these numerous new weight-loss drugs, the US FDA proposed a new regulation in the original approval process: All new weight-loss drugs that apply for listing in the United States must have over 1500 (obese) volunteer subjects. The scale of the tester population was double-blind controlled clinical trials of the drug, and the trial time must not be less than 12 months. Then, the second clinical trial (there must be no less than 500 obese participants) was used to determine the actual weight loss of the new drug.

In these two trials alone, new units for weight-reducing drugs need more than 100 million U.S. dollars.

The discussion on the safety of diet pills has not stopped with the restart of approval. Recently, the US FDA advisory team even considered the 17:6 vote that regulators should require pharmaceutical companies to conduct cardiac safety studies on their drugs--even if the initial clinical trials did not show evidence of increased risk of heart disease.

If this requirement is finally approved by the FDA, the production and final sale of diet pills will face a higher regulatory threshold.