Trisha Roiger
Health 240: 07
FDA Regulation The Food and Drug Administration is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription, over-the-counter drugs and etc. The FDA also enforces other laws, many of which aren’t directly related to food or drugs. The FDA regulates drugs by requiring that the producers of prescription and over-the-counter drugs must demonstrate a drug's safety before it is allowed to be placed on the market. Drugs are tested by their producer for an average of 8.5 years in both labs and clinical trials (Discovery). Following these tests, the producers must file an appeal to the FDA for the drug's approval (Discovery). If the FDA approves the drug, it's classified as a prescription or over-the-counter drug. If not, the drug can't be sold in the United States. Approximately 0.1 percent of drugs tested in labs gain FDA approval. Some people may or may not agree with this procedure. Each time Congress enacts a law affecting products regulated by the Food and Drug Administration, the FDA develops rules to implement the law. The FDA takes various steps to develop these rules, including publishing a variety of documents in the Federal Register announcing the FDA's interest in formulating, amending or repealing a rule, and offering the public the opportunity to comment on the agency's proposal (FDA). The Federal Register notice explains the legal issues and basis for the proposal, and provides information about how interested persons can submit written data, views, or arguments on the proposal (FDA). Any comments that are submitted are addressed in subsequent publications that are part of the agency's decision-making process (FDA). No, the first amendment protection of free speech should not extend to off-label marketing by pharmaceutical companies because this would give the companies a right to say whatever they want about the drug, even if the drug is providing negative effects. The drug Bextra was pulled from the market because it produced a rare and sometimes fatal skin reaction that outweighed the benefits of its use. The FDA allows doctors the freedom to prescribe medications as they see fit, but it doesn’t extend the same freedom to what sales reps can say about the drug, which is good because companies can flaunt a drug in beneficial ways and not speak about the negative effects also. Sales reps job is to help make profit off of a drug after the FDA approves it and sales reps will do anything to make a drug look great than care about the health of humans of not stating the negative effects also of the drug. If the off-label marketing remains illegal or is legal in the near future, people will continue to be upset either way. It is more challenging these days than times such as the 1800’s and 1900’s to get drugs. The FDA makes it harder for people to receive drugs that they need for medical uses. The FDA does this because there is a high use of drugs in America. When some people are prescribed drugs they overdose and try to get refills to abuse and misuse the drug.
It is argued that the FDA’s control over drugs and devices has large and often overlooked costs that almost certainly exceed the benefits. It is believed that FDA regulation of the medical industry has suppressed and delayed new drugs and devices, and has increased costs, with a net result of more morbidity and mortality (FDA Review). A large body of academic research has investigated the FDA and with unusual consensus has reached the same conclusion (FDA Review).
The increased costs of drugs can damage a person’s budget because drugs are effective and some have negative effects, but they are hard to buy when the price is high and has to be approved by the FDA. The FDA approves drugs, but the freedom of speech should not extend to off-label marketing.