How Are Drugs Regulated?
In the US, pharmaceutical companies are regulated by the Food and Drug Administration (FDA). The FDA is the governmental agency in charge of enforcing pharmaceutical compliance in the US. The FDA continues to monitor the pharmaceutical industry and the companies that produce, develop and market drugs in the US. The primary goal of the FDA and its regulation of pharmaceutical products is to protect consumers from products which are unsafe. The FDA works to regulate, inspect, recall and sample products to ensure their safety. They also regulate foreign products which are imported into the US.
History of the FDA and Pharmaceutical Regulations
Over the last one hundred years the government’s involvement in controlling and regulating pharmaceutical products has gone from nothing to very far-reaching. Presently, pharmaceutical products are the most regulated products in the US. There are two main legislative acts which delegate the FDA’s power and they were both created following significant tragedies.
In 1937, the Massengill Company attempted to make their new antibiotic more palatable and they used a solvent called diethylene glycol to do so. This substance is also used as an antifreeze product. Before the drug was recalled, it had killed over a hundred people, mostly small children. The company was sued and the chemist behind the drug committed suicide as a result. The tragedy was what led to the Food, Drug and Cosmetic Act of 1938. This Act required that drugs be proven safe before they were put on the market. The second significant occurrence which led to the Kefauver-Harris Amendments of 1962 occurred when over 10,000 European babies were born deformed. The common thread in their deformities was that their mothers took thalidomide in order to alleviate the discomfort of morning sickness. Even though the FDA already had regulations which helped provide safety precautions, but at this point they added the proof of efficacy.
What is the approval process for new drugs?
It can be time consuming, difficult and expensive to get a new or old drug approved by the FDA. There is a lot of paperwork that has to be done prior to getting a pharmaceutical product approved for use. There are literally reams of data which disclose the tests that prove the medication is both safe and effective for treating a particular illness; and it’s very specific regarding what types of conditions it can treat. A drug’s effectiveness to treat a specific condition or disease is called an “indication.” After the drug is approved by the FDA, then the manufacturer can advertise the use of the drug for that indication only. The approval process is so arduous that in most cases drug makers do not submit multiple applications to the FDA for the various uses a drug might have. The entire process has to be repeated for each separate indication that the manufacturer wants to have approved. For this reason, in most cases new drugs are approved only for one or two major indications even though they might be effective for more. Drug makers will usually seek approval for the indicators which represent the largest portion of the market.
How the FDA Restricts and Qualifies Clinical Investigators
The FDA also monitors and regulates the studies that are used to develop pharmaceutical products. The goal is to ensure the safety and effectiveness of investigational drugs for both animals and humans. Experts who are testing pharmaceutical products have to comply with various regulations so that the integrity of the data is ensured. If any expert fails to comply with the FDA regulations, they can be disqualified which means that the drug ultimately will not be approved for use. The FDA may also disqualify any individual or group which submits false information to the FDA or to the sponsor. When an expert is disqualified or restricted by the FDA, they will not be able to receive any drugs, biologics or devices. The FDA is very serious about protecting the integrity of the application process. The Application Integrity Policy is in place to deal with the integrity of the many applications which are submitted to the agency for review and approval. When the FDA has any reason to suspect an application of providing any type of misleading or falsified information, they will investigate the applicant. The policy (AIP) is effective in ensuring that the application procedure is consistent.
History of the FDA and Pharmaceutical Regulations
Over the last one hundred years the government’s involvement in controlling and regulating pharmaceutical products has gone from nothing to very far-reaching. Presently, pharmaceutical products are the most regulated products in the US. There are two main legislative acts which delegate the FDA’s power and they were both created following significant tragedies.
In 1937, the Massengill Company attempted to make their new antibiotic more palatable and they used a solvent called diethylene glycol to do so. This substance is also used as an antifreeze product. Before the drug was recalled, it had killed over a hundred people, mostly small children. The company was sued and the chemist behind the drug committed suicide as a result. The tragedy was what led to the Food, Drug and Cosmetic Act of 1938. This Act required that drugs be proven safe before they were put on the market. The second significant occurrence which led to the Kefauver-Harris Amendments of 1962 occurred when over 10,000 European babies were born deformed. The common thread in their deformities was that their mothers took thalidomide in order to alleviate the discomfort of morning sickness. Even though the FDA already had regulations which helped provide safety precautions, but at this point they added the proof of efficacy.
What is the approval process for new drugs?
It can be time consuming, difficult and expensive to get a new or old drug approved by the FDA. There is a lot of paperwork that has to be done prior to getting a pharmaceutical product approved for use. There are literally reams of data which disclose the tests that prove the medication is both safe and effective for treating a particular illness; and it’s very specific regarding what types of conditions it can treat. A drug’s effectiveness to treat a specific condition or disease is called an “indication.” After the drug is approved by the FDA, then the manufacturer can advertise the use of the drug for that indication only. The approval process is so arduous that in most cases drug makers do not submit multiple applications to the FDA for the various uses a drug might have. The entire process has to be repeated for each separate indication that the manufacturer wants to have approved. For this reason, in most cases new drugs are approved only for one or two major indications even though they might be effective for more. Drug makers will usually seek approval for the indicators which represent the largest portion of the market.
How the FDA Restricts and Qualifies Clinical Investigators
The FDA also monitors and regulates the studies that are used to develop pharmaceutical products. The goal is to ensure the safety and effectiveness of investigational drugs for both animals and humans. Experts who are testing pharmaceutical products have to comply with various regulations so that the integrity of the data is ensured. If any expert fails to comply with the FDA regulations, they can be disqualified which means that the drug ultimately will not be approved for use. The FDA may also disqualify any individual or group which submits false information to the FDA or to the sponsor. When an expert is disqualified or restricted by the FDA, they will not be able to receive any drugs, biologics or devices. The FDA is very serious about protecting the integrity of the application process. The Application Integrity Policy is in place to deal with the integrity of the many applications which are submitted to the agency for review and approval. When the FDA has any reason to suspect an application of providing any type of misleading or falsified information, they will investigate the applicant. The policy (AIP) is effective in ensuring that the application procedure is consistent.