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FDA (Food and Drug administration) updates

FDA Medication Guide

The FDA has a medication guide page that replicates the paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. 

You can use these guides in case you want to research a drug before taking it or if you lose the paper guide.

The FDA requires that medication guides be issued with certain prescribed drugs and biological products when the FDA “determines that: • certain information is necessary to prevent serious adverse effects • patient decision-making should be informed by information about a known serious side effect with a product, or • patient adherence to directions for the use of a product are essential to its effectiveness”. 

If you are taking a prescription subject to a guide, you can sign up for email alerts when medication guides are updated.

The complete list of medication guides is available at the FDA website.

FDA Votes in new commissioner

The Senate voted 57 to 42 on May 9, 2017 to confirm Dr. Scott Gottlieb as commissioner of the Food and Drug Administration. Many, including the attorneys at, have expressed concern that he will be responsible for regulating drug companies to which he has had close ties in recent years. The FDA regulates everything from tobacco to food to drugs and medical devices. In fact, the FDA is so huge that products regulated by the FDA account for 20 cents of every dollar spent by American consumers each year.

Dr. Gottlieb has written prolifically on F.D.A. policy as a fellow at the conservative American Enterprise Institute, as well as often working for those industries. Over the years, Dr. Gottlieb has been a frequent consultant to drug companies, serving on advisory boards for large pharmaceutical companies like GlaxoSmithKline. He has also invested significantly in the health care industry. Dr. Gottlieb has promised to divest himself from several health care companies and recuse himself for one year from decisions involving those businesses.

During the administration of President George W. Bush, Dr. Gottlieb held various jobs at the F.D.A., including deputy commissioner.

Supporters of Dr. Gottlieb’s nomination have said his business experience will serve him well as head of the FDA.

At his confirmation hearing in April, Dr. Gottlieb told senators that he believed in upholding the FDA’s reputation as the world’s “gold standard” for drug approval. If confirmed, he said then, he would be “an absolutely objective regulatory watchdog” and would not do anything that could “besmirch the agency” or undermine public confidence in its work.

We are no fans of the FDA generally and having a commissioner with such deep ties to Big Pharma is deeply troubling. It remains to be seen how it works out. There is a lingering myth that a drug approved by the US Food and Drug Administration (FDA) is safe. It is the firm opinion of that the FDA stamp of approval is not the criterion for safety or what is actually safe for human consumption.

Are FDA Drugs Safe To Use?

There is an incredibly long list of drugs that are, or have been, approved by the FDA that are not “safe”.

There are two problems with the assumption that the FDA actually serves the interests of the American people. First, the interests of the pharmaceutical industry are frequently considered. There is an alarming amount of crossover between the employees of the FDA and the pharmaceutical industry. Our experience has shown that the FDA is not an aggressive guardian of the American public at all.

The second problem is the way the FDA actually approves a drug. While there is no doubt it is a lengthy and expensive process to get a drug FDA approved, the myth is the FDA actually tests these drugs to make sure they are safe.

The FDA describes the process this way:

Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labelling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The centre doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.

As you can see, the FDA simply analyzes the data given to them by the drug company. Perhaps this is part of the reason why unsafe drugs continue to be FDA approved but then go to kill and injure so many Americans.

The strongest advice from the attorneys at is to do your own research. At a minimum, please just don’t blindly take a drug, even if your doctor wants to prescribe it. First, ask your doctor questions about side effects, the length of time the drug has been on the market, problems with similar drugs and other such questions. It may be that your best course of action is to take the drug but understanding that the drug is not automatically safe may be very helpful in safeguarding your health.

Please contact us at 1(855) 464-0808 or for a free legal evaluation of your claims today!

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FDA Inspections

One of the core missions of is to help educate the American public about the dangers of Big Pharma. It is generally assumed that these big companies have our best interest at heart and that the FDA keeps them in line. We believe neither of these to be true. Thus, it is disheartening to us to see how some drug makers behave. Through the Freedom of Information Office, regularly obtains notice of ‘Violation Letters to Pharmaceutical Companies’. We are often disgusted by the contents of these letters.

For example, in a letter dated January 2017, the FDA warned a drug maker after inspecting a drug manufacturing facility in February 2016. The FDA investigator observed “rust, insects, damaged interiors, and/or drug residues in pieces of manufacturing equipment”. Would the average American expect these finding? And how many facilities operate without adequate FDA inspection or oversight?

One step we encourage consumers to take is to research any medical devices or drug yourself before you have them implanted or consume them. Ask questions about the manufacturer. Do they have a history of FDA violations? Have they been sued for making bad drugs or faulty medical devices? How many times? Is the particular drug or medical device that is being recommended under the cloud of any lawsuits or warnings? Is the drug available overseas? If so, what warnings does the drug manufacturer give consumers overseas?

Although it is tempting to trust your doctor, and avoid the individual research, our experience has shown that neither doctors, the FDA or the pharmaceutical industry can be fully trusted with your health. Just remember: rust, insects and drug residues. Please contact us at 1(855) 464-0808 or for a free legal evaluation of your claims today!

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