It takes 10-15 years and hundreds of millions of dollars For pharmaceutical companies to go through the Food and Drug Administration’s (FDA) regulatory process and bring new drugs to market. Many seriously ill people die waiting for the FDA to approve drugs that have already been approved by regulators in other developed countries, a phenomenon known as .drag rug“Imagine how many treatments remain undiscovered and how many people suffer needlessly because pharmaceutical companies have to divert excess R&D dollars to the drug approval process. This is a phenomenon called “It’s impossible.”drug loss. ”
Congress passed the Food, Drug, and Cosmetic Act (FDCA) in 1938 to ensure drug safety. The new law exempts medicines that people have been using for years, such as aspirin and regular insulin, from the FDA approval process. But drug companies will now also be required to provide convincing evidence to authorities that any new products are safe for patients to take as directed. When Congress passed the Kefauver-Harris Amendment to the FD&C Act in 1962, drug companies had to convince the agency that their new drugs were effective and safe, requiring millions of dollars and millions of dollars in the approval process. An additional year was added, lengthening the approval period. An institution that allows people to take medicines.
Oddly enough, when the FDA finally allows drug companies to sell drugs for the specific conditions listed on their labels, the FDA will allow clinicians to sell drugs for any condition they believe will be effective. be allowed to recommend the drug to patients. from anywhere 1/5 to 1/3 Of all the medicines that clinicians prescribe and people consume, these medicines have these “off-label” uses.
In other words, the FDA forces drug companies to prove that a drug is effective against symptom A, but it is up to the private sector and academics to determine whether the drug is effective against symptoms B through Z. This is left to clinical researchers in the field. Why doesn’t the FDA defer to clinicians’ judgment about symptoms? a?
There may also be benefits from using off-label drugs. For example, clinical researchers found that thalidomide, an anti-nausea drug that causes birth defects when used by pregnant women for morning sickness, is effective in treating leprosy and multiple myeloma when prescribed off-label by clinicians. did. Similarly, doctors recommended off-label aspirin to prevent cardiovascular disease. On the other hand, clinicians may find that off-label use of a drug may be harmful or inappropriate. For example: Deaths caused by elixirsulfanilamide in 1937 It happened when the doctor prescribed it Off-label purposelike Bright’s disease (an old name for kidney inflammation), mercury poisoning, and back pain.
For off-label uses of drugs, approval of efficacy is done by the company. Different from FDA. In addition to publications such as consumer reportthese include peer-reviewed medical journals. United States Pharmacopoeiaand several other private compendiums. Federal law requires the Medicare and Medicaid programs to rely on certain privately compiled drug compendiums to prove the effectiveness of off-label uses. Just as the government allows doctors the freedom to prescribe prescription-only drugs for off-label uses, it also allows patients the freedom to use over-the-counter drugs for off-label purposes.
The FDA even relied on a private, third-party review agency, the National Research Council of the National Academy of Sciences, to test the effectiveness of drugs from 1938 to 1962. Conducted safety and efficacy evaluations From long before Congress passed the FDCA until it was shut down by the FDA and ceased operations in 1955. Still, it is registry To report drug reactions.
One intermediate step toward pharmaceutical freedom and progress would be for Congress to enact “.international pharmaceutical reciprocityThis will give U.S. doctors and patients access to drugs and devices approved by similar, reputable national regulatory authorities. There is no logical reason why Americans cannot access products approved in countries such as Canada, France, the United Kingdom, and Switzerland. , Australia, New Zealand and Israel have been working on reciprocity for many years.
Many people can’t imagine a world where the FDA doesn’t have a monopoly on drug approvals. However, there will always be a market for information about drug safety and effectiveness. Ending the FDA’s monopoly allows for innovation and competition in the field, which benefits everyone, including former FDA officials.
