Lack of Testing
Research studies are critical in providing information on drug safety, quality and effectiveness. The U.S. Food and Drug Administration is the government agency that is tasked with evaluating, approving and monitoring the safety of drugs and a range of other products. It is supposed to serve as the watchdog to protect the American public from “quackery” and dangerous medications.
But, as the Boston dangerous drugs lawyers at The Law Offices of Jeffrey S. Glassman know well, it often fails in this regard. In fact, the FDA’s Center for Drug Evaluation Research, while conducting limited research, doesn’t actually independently test the drugs. Rather, it’s more often the manufacturer that is tasked with reporting the benefits and risks in clinical trials, which are paid for by the manufacturer.
More often than not, academics on drug company payrolls and pharmaceutical industry insiders are the ones conducting this allegedly “objective” research.
Aside from that, there are a number of ways drug companies can accelerate the approval of certain products, which means there is even less quality control.How FDA Approval is Supposed to Work
The CDER is responsible for examining and approving applications for new drug compounds, generic drugs and over-the-counter medications. On average, the process from discovery to market should take between 8 and 12 years, and includes a battery of clinical tests and independent reviews.
- Step 1 – Discovery and Development. Researchers discover a new drug through a myriad of ways, and promising compounds are flagged for development. Experiments are conducted on potential benefits, how it’s absorbed and metabolized, best methods of distribution, potential side effects, interactions with other drugs and treatments and effectiveness in comparison to other drugs.
- Step 2 – Preclinical Research. This is research that takes place not on human beings, but either on isolated cells in a lab or on animals. These studies typically aren’t very large, and researchers use the findings to decide whether additional studies should be conducted on humans.
- Step 3 – Clinical Research. These are studies and/or trials that are done in people. Researchers have to identify specific research questions for each study and they have to adhere to a strict protocol, developed either by the manufacturer or the researcher. Sometimes, this protocol is called a “study plan,” and it spells out the number of participants, the length of the study, who will qualify to participate, how the drug will be given and other details. There are typically four phases of clinical trials, the first starting with 20 to 100 people and the gradually working up to more participants and studies for longer periods of time.
- Step 4 – FDA Review. If the drug is found in testing to be effective and safe for its intended use, the pharmaceutical company can apply with the FDA to market the drug. The company lists the data from studies, proposed labeling and safety information. The FDA then takes that information and a review team makes sure the application is complete. If not, the team may refuse to file it. Sometimes, additional information or testing is required. Even if there are no major issues, FDA review and approval can take 6 to 8 months.
- Step 5 – FDA Post-Market Safety Monitoring. This involves routine inspections of drug manufacturing facilities, review of supplemental applications for any significant changes that will be made to the original drug, requests to approve the drug for new uses or in different doses and ensuring drug advertising adheres to the law.
It’s worth noting that, again, all of this research is conducted either directly by the manufacturer or researchers paid by the manufacturer.Speeding Up the Approval Process
The lengthy process as outlined by the FDA is intended to ensure the drugs on the market are as safe as possible for the public. But there are a number of ways that drug companies can sidestep this process and get their product to the public sooner.
These processes include:
- Priority Review. This is a designation for drugs that are asserted to offer “significant improvements” in the effectiveness or safety of prevention, diagnosis or treatment of serious medical conditions, as compared to what is already available. FDA approval can take as little as 6 months.
- Breakthrough Therapy. The FDA will expedite development and review of medications that aim to treat a serious condition, assuming preliminary clinical evidence suggests a substantial improvement over what is currently available.
- Accelerated Approval. Congress in 2012 passed the Food and Drug Safety Innovations Act, which in part allows the FDA to expedite approval for drugs that fill an unmet medical need for serious medical conditions.
- Fast-Track. This designation is requested by the drug company and allows expedited approval for drugs that offer resolution of an unmet medical need. A decision on a fast-track designation is made within 60 days.
When drugs are expedited into consumer medicine cabinets, there is legitimate concern over whether the potential risks and side effects are fully fleshed out.Other Testing Concerns
In particular, it’s been noted the FDA faces significant challenges when monitoring and inspecting foreign clinical trials. This is a big problem because India, for example, is the second-largest drug exporter to the U.S., with most producing generic drugs. Bloomberg reported the top 10 pharmaceutical companies based in that country rake in $15 billion in U.S. sales annually.
A 2010 report by the Office of Inspector General for the Department of Health and Human Services indicated 80 percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials. Further, the FDA inspected clinical investigators at less than 1 percent of those foreign sites.
If you have been injured or suffered illness as a result of dangerous drugs, our experienced Boston injury attorneys are waiting to answer your questions.
Contact the Boston personal injury lawyers at The Law Offices of Jeffrey S. Glassman by calling (617) 367-2900.