Legislative Alert - Write Your Legislators

Take a minute to write to your legislators in opposition to several bills that are designed to rescind immunity from liability for drugs that have been approved by the Federal Food and Drug Administration (FDA). These bills include House Bills 4773, 4811, 5071 and 5139.

As family physicians, you deal with new and old prescription drugs on a daily basis and see the impact they have on the quality of life of your patients. We believe that everyday the FDA must balance the needs and hopes of patients waiting for new treatments against the need to ensure that the medicines being studied are safe and effective. Repealing this lawsuit abuse law implies that a drug researcher must know every possible risk before a drug can be available for patients. That is simply not possible and doing so would keep millions of patients waiting unnecessarily for medicines to save their lives or to improve the quality of their life. That’s not good healthcare.

In addition, every medicine has risks and benefits and patients should discuss them with their family physician. All medicines have side effects and that is precisely why prescription medicines can only be used by patients at the direction of a physician. This also is why, by law, every drug must list its known common and even rare side effects.

There’s a lot of misinformation about Michigan’s existing lawsuit abuse law. If a patient believes that a drug maker may have acted fraudulently or misrepresented safety information, they can go directly to the FDA and share those concerns. If the FDA determines a company misrepresented its drug to the FDA or withheld information about the drug in order to win approval, patients may sue. The current law just makes sure trial lawyers have a just reason before starting endless rounds of lawsuits which add to the growing cost of healthcare.

Companies have both a regulatory and ethical obligation to monitor ongoing safety concerns and to report them to the FDA. In addition to reporting to the FDA, should new safety questions arise, companies and the FDA work toward changing the drug label to reflect this new information. Important new information is always communicated to the medical community in a timely manner, for example “Dear Doctor” letters to health care professionals.

From the drug safety perspective, the U.S. Food and Drug Administration is responsible for assessing the efficacy and safety of drugs before they reach patients. Most experts regard FDA’s extensive review as the “world’s gold standard.” If the FDA concludes a drug is safe to market, then it is just common sense for the company that made the drug to be protected from litigation when it complies with every regulatory and safety issue required. Of course, all prescription drugs have some risk associated with their use. These are powerful treatments and patients should always discuss the risks and benefits of their medicines with their physician.

We hope you will take a minute to email, write or call your legislator about this package of “drug immunity” bills.

Click here to write your legislator!

If you have questions or would like to speak with us, please contact the Academy at
1-517-347-0098 or info@mafp.com.