The food and drug laws are famous worldwide for their rigour. However, in one surprising respect, this reputation may not be wholly deserved. It turns out that there are still thousands of unapproved drugs available. How has this situation come about?
Repeated tightening of the law
The Food And Drugs Act of 1906 first brought the regulation of drugs under federal law, making the sale of misbranded or adulterated drugs an offence. Although the sale of these drugs was prohibited, the Act did not say that drugs needed to be approved by the FDA. This situation clearly had to be addressed, and in 1938, Congress decided that all new drugs had to go through safety approval.
A drug may well be safe, but it might also be completely useless. In 1962, Congress amended the law so that manufacturers had to demonstrate that drugs were not just safe but also effective. As part of this initiative, all of the drugs that had been passed as safe between 1938 and 1962 had to be put through a repeat review process to see whether they were effective or not.
All new drugs now have to have an approved application, including FDA 510k clearance submission so that they can continue to be sold. We now live in a society where if drugs are wrong or are taken incorrectly people will sue. If your a business that deals with customers or consumers then you probably will want High Net Worth Insurance Gloucestershire which you can find on sites like https://johnmorganpartnership.co.uk/. This will protect you in case any thing happens that is not expected.
Confusion over generics
However, many drugs that are prescribed come in packaging that doesn’t reveal that they do not have FDA approval. Many of these drugs don’t have recognisable brand names and because they’ve been around for years, many healthcare providers think that they are generics. This is a mistake because generic drugs, like new drugs, have to go through the FDA evaluation process and will have had to demonstrate that they are the equivalent of a specific branded drug. Generic drug products that have been approved by the FDA have also had to show evidence that they have the same security, stability, strength and quality as the brand-name drugs they reference. In addition, the manufacturing, testing and packaging has to be of the same quality level as the brand-name drug.
Healthcare professionals need to be aware that an unapproved drug is not the same as a generic one and that its safety and effectiveness cannot be guaranteed.