Your FDA (2\2): 1950’s to 2007
One thing important to note, during the years 1955 to 1956 the concept of clinical trials by the Bureau of drugs and medicine in the FDA began it consisted of phase one, two, three.. Everything seemed to be going right but things began to change tragedy happened when the polio vaccine was contaminated at the Cutter lab at Berkeley California. A widespread outbreak of Polio from the vaccine occurred.
We now had new classes of drugs such as antibiotics, hormones, amphetamines, and barbiturates, but not leave out medical devices, insecticides, and coloring. The FDA felt they were doing their job, they were protecting the blood supply came up with the new vaccines, but there was a new hazard called radiation.
I believe they failed or had no idea what would be in front of them in years to come. Where the fallout was detected during the 50’s matches high outbreaks of disease; clusters of people within communities. No one would know this for years to come, and no one would ever be to blame when these areas where radiation was at its highest would cause a large population of cancer, and diseases know as multiple sclerosis, and more.
Now we had another agency called the United Nations Atomic Committee on the effects of radiation – the fallout for future generations. The concern stretched to normal x-rays, nuclear power plants which were just beginning.
Additional centers opened, one being the center for devices and radiological health. By 1958 the medical x-ray became a concern. Imagine all the people who were subjected to the common Xray and felt no fear. So began the Bureau of Radiological Health.
As we entered the year 1959 a Senator named Estes Kefauver, led the investigation of price fixing, marketing, and side effects of pharmaceutical medicine. It was believed that false advertising caused injury to many and Kefauver believed you cannot sell a product and pay no attention to the side effects. It was time for more regulations, and more protection to serve the people.
If you recall or have read about the disaster during this time when the FDA received an application, from a German Company marketing their drug called – Thalidomide – it entered the United States, and considered safe for the consumer, it was not. The company, Kevidon, had labeled this drug. Here in the states, the Merrell company introduced it to 20,000 patients which included about 6,000 pregnant women. The drug, delivered to doctors to use all over the country. The Merrell Company suspended the drug when they learned pregnant women lost their fetus, or infants were born without limbs and other deformities. The drug was known to be a sedative. At this time, Congress moved forward to pass major changes in the FDA Act.
By the 1960s the FDA had amendments to their act which were safety testing — drugs must be safe and effective from abroad or home. At this time for phases of clinical drug testing began.
Phase 1 who would take part — 20 – 100 patients, the duration would be several months, and the purpose was safety of treatment, drug side effects, and safe dosage.
Phase 2 who would take part — several hundred patients, the duration months to two years, and the purpose of continued evaluation and effectiveness of safety.
Phase 3 who would take part — several thousand patients, lasting from 1 to 4 years, monitor side effects and compare to other treatments and collect information.
After 1962 many things were imposed by the government such as drug accountability, tax his city and animals, clinical trials on human subjects, and good manufacturing practices. The government had requirements they were to search for a new drug in a lab with an extensive study using rats or small animals. But there was a glitch in the system because each manufacturer had the opportunity to set up their own lab and they would submit results of the animal tests to the FDA. Submission of a proposed plan for clinical testing on human subjects would be sent to the FDA stating the manufacturer had proof of its use and safety by the testing made with small animals, now asking permission to sell it. With our growing population and the use of more drugs, we lost control of safety. We no longer had enough inspectors in the field but applications were sent to the FDA for review by both Medical and a Scientific Staff at the FDA, and if the drug was approved, it would be noted by the Commissioner of the FDA.
By the late 1960s, the Government and the FDA came under different listings. At the top, you would read the Department of Health, Education, and Welfare. Just below from the left, it would read – FDA, National Institutes of Health, Social Security Administration. It was in the late 1960s when the FDA became a part of the public health service. By 1971 the Bureau of Radiological Health moved in to the FDA. By 1972 the Bureau of biological standards followed. In addition, a new Drug and Abuse
Program followed along with the Environmental Protection Agency.
The method every viewing a drug change in the 70s requiring an adequate personnel for inspection to go to the facility to see how it worked on the inside and make sure that everything was done properly.
Now we entered the stage of talk and FDA enforcers we were dealing with a huge population using thousands of drugs. The requirements from the GMP were; defined responsibility for management and control, quality control testing, adequate number of trained personnel, adequate facilities with clean equipment and up to standard, storage and labeling controls, defined the recipe for product and explanation of any deviation.
As mentioned before the FDA inspectors could not cover this entire country and roll plants began to open, and many inspectors began looking around to see if the plant was clean and all other requirements as stated above were taking place. These controls on all manufacturers were out of hand although the inspectors would call in a problem if one was found. What occurred the industry used their own inspectors, and test the item, and control process which statistics.
Now the HACCP came into play.
By 1978 they ceased drug articles that were not manufactured right it was only right to do so and not wait until something went wrong. But in the late 70s two scandals of fraud and abuse occurred the subject; ethical human subjects and review boards. It was in the late 1970s when wide spread fraud in animal testing labs occurred.
So this began the air or of rulemaking from 1970 through 1998 was noted that regulations must go through a federal register subject to explanation as to what they need etc. it would not be until 1990 when the FDA adopted guidelines and issued documents to interpret the law. To regulate the industry and make science more complex and industry had to comply to the law.
They believed it would work until the issue of saccarine. The FDA found the use of saccharine could cause bladder cancer, and told Congress the public should be aware, but Congress opposed the thought of stopping the manufacturing of saccarine, but agreed to warning labels on any product containing the additive. The sacarine study act still requires warning labels.
Things began to change in the 70s labels on food that good and the bad, from fat, salt, fiber and the impact of b ad saturated fat. By the 1980s things changed again a complete ingredient labeling on food wasn’t necessary according to the FDA, and free back chronic disease by consuming less saturated fat.
From the 80s to the 90s anti-regulatory – during the Reagan administration. Government stated that government is not part of the solution its part of the problem, and 1000 jobs were cut from the FDA.
It was during the 1980s and the HIV epidemic occurred. People requested that drugs be approved faster but the FDA needed new jobs and had no money. This load up the drug approval — it was a Republican White House by the Democratic House. By 1984 five centers opened in Washington DC, these were; FDA Center for food and applied nutrition. CDER human drug Center for drug evaluation and research. CDRH Center for devices and radiological health. CVM Center for veterinary medicine. CPER Center for biological evaluation and research. ORA office of right to the Tory affairs around the country. After DNA national Center for tax a logical research.
DNA guidelines concerning rubella — biological evaluation and research regarding the rubella vaccine and investigational new drugs.
David Kessler had at the FDA investigated cancer related to tobacco products. The FDA wanted to regulate it as a drug and put the cigarette companies out of business and Congress said no. Advertising began a campaign against the drunk driver regarding manslaughter and everyone believed that the FDA was doing their job. During this time scientists concentrated on the drug/life issue regarding the application and approval for a new drug being 36 months stating they were losing money and people were dying.
From 1986 to 2000 — the new drug review time of 36 months was in effect and the industries who manufactured drugs paid a substantial amount of money. This went on to the supplement and dietary field regarding nutrition bees products were not regulated as drugs no one knew what was toxic and what was not as the FDA was the gate keeper for quality and safety.
In 1999 the Court of Appeals reported FDA activities were subject to commercial free space — they could not say a label is misleading.
By the year 2007 advertising had to tell all the side effects of a drug since advertising before this time told of the good – not mentioning the bad. This is when Paxil was removed from the market because of the FDA Amendment Act of 2007. Statistics should Paxil and Vioxx caused many problems the FDA amendment disclosed in few words, if there is a problem research it, pull the records, and in these cases, they had 100 million medical records to read – in a 3 – 4 month time period. Those drugs were then pulled from the market. Remember the law read the manufactures of the drugs were responsible for testing and revealing the outcome.
Many people feel we have too many drugs or regulatory actions which keep drugs from going to market but the truth is we don’t know. The job of the agency is to protect the health of the American people although far too many people are going without a drug that is available either because of cost, or it is not available. These people suffer from many of the orphan diseases, not enough money to invest money into research and human trials. Even some of the drugs on the market are not covered by many insurance companies, due to the cost – a friend of mind uses over 9,000 dollars a month for injections and two pills in tablet form. Her husband is self employed, his insurance will not cover her medication, since she must use Medicare. The safeguard of the FDA; strong regulations, trusting the system, consumer protection, and no big budget. They believe in strong laws, truth in labeling, and civil servants. I believe in doing the best for the people, and can recall the 1980’s when the FDA lacked the workers to get the job done right.
One thing that strikes me funny, or odd – how important the people are to the FDA yet those are the people who can’t receive coverage for a known disease. The connection with Social Security, down the line, should bring about questions from the young and old, concerning the high cost in drugs, and our local pharmacy has long waiting lines. Regardless of what is written here about the before, I must end it with the future, where will all the people go for care when they are turned away from qualified doctors, because of their age and using the Medicare, and the cost of drugs, let alone finding a doctor to serve your health problems. It is only right the elderly and those who are using Medicare – only for their health coverage, due to a disability, be recognized in this agency. I waited through three debates and many long years for conversations about Medicare to include those living with a disability.
The reason it’s quiet and ignored has been someone’s secret within the government. You see, those who receive SSI because of a disability are also receiving payments from Medicare to cover a vast array of problems it will have to be another post. It is now time to look back, and become involved in the future through experience.