Waiting on the Government
Perhaps those at the Food and Drug Administration (FDA) who are responsible for more delays in the approval of the drug Eteplirsen were inspired by the imaginative approach of their colleagues at the Department of Veterans Affairs, who compared the long delays in treating veterans to waiting in line at Walt Disney World. It is "the quality of the overall experience" that the VA says we should consider, not the time it takes. . . . Read more
First, Do No Harm: A Few Simple Rules for the FDA
You and your physician should not have to ask the FDA for permission to use a medication. If you have a terminal illness, you should especially not have to ask the FDA for permission to live. Unfortunately current law says that you do. The U.S. Supreme Court has ruled that you must comply with that law. . . . Read more
FDA Horror Stories
You may think you have the right of access to drugs that could save your life. But at the urging of the Federal Drug Administration, the U.S. Supreme Court does not agree.
The FDA has vigorously defended its power to deny drugs to the terminally ill, and it has been successful. Apparently, you have no right to the use of any drug without government permission, no matter how long it takes to get it, if ever. And the FDA has no sense of urgency about anything except the preservation of its own powers. . . . Read more
The Power of the FDA Must End
The Food and Drug Administration is a huge, unwieldy, distant and indifferent bureaucracy. After more than a century of regulation, it follows a well-established pattern in the history of the U.S. Government. It relentlessly, voraciously and persistently seeks to increase its spending, regulations, authority and staff. The result is the subordination of the best interests of patients in favor of serving the FDA’s congressional and ideological patrons. . . . Read more
Asking the Government for Permission to Live
The Food and Drug Administration has gone to court to prevent the Colorado-based firm Regenerative Sciences from using stem cells developed in one part of your body (bone marrow) to repair damage in other parts of your body, such as joints. The FDA objects to the fact that these cells are chemicals, the use of which the agency has the power to regulate even though the cells are taken from your body to later be injected back into your body. . . . Read more
Freedom from the FDA
The FDA adds billions of dollars to the cost of developing new drugs and delays their use for years. Yet it is so obsessed with predicting exactly how each drug will perform for any patient—with any condition, in any dosage, for any length of time and in any combination with any other drug or combination of drugs in any dosage—that it often loses sight of safety. So a few years ago the FDA proposed the creation of a new "Drug Safety Board" to provide for drug safety. One would have thought that was the purpose of the whole agency. . . . Read more
Finding Alternatives to the Food and Drug Administration
First of all, we need to realize that neither the FDA nor anyone else can do the impossible. When a new drug comes to market, no one can know all of its side effects, nor the impact on all other medical conditions that a patient might have, nor how it might interact with any dosage of any combination of an infinite number of other drugs—nor the cumulative effect of ten, twenty, or thirty years of use. If omniscience is required, no new drug will come to market. The good news, however, is that computers and the Internet now provide excellent tools to accumulate and tabulate data on the impact of every new drug. . . . Read more
Free Markets: The Key to New Drugs at a Reasonable Price
The U.S. pharmaceutical industry spends $22 billion a year on research and development of new drugs. Unlike government-funded research—which can be spent to develop drugs that no one needs or that duplicate existing drugs—pharmaceutical companies must get results. In order to recover their investment, their new drugs actually have to work. The continuing flow of new drugs that these firms produce is the best hope we have to treat and cure our ailments. . . . Read more
A Prescription for Disaster
At a cost of $400 billion over 10 years, Congressional Republicans have agreed in Conference Committee—with the enthusiastic encouragement of a Republican president—to the greatest expansion of government in two generations. This new Medicare program can only result in what government supplied health care has always produced in the U.S. and elsewhere: fewer new drugs and a lot more government. Of course, after a few years in practice we all know the program will end up costing a lot more. . . . Read more
Welcome to Freedom from the FDA.
Our objective is to provide a resource for all of those concerned about the power of the Food and Drug Administration to damage the free practice of medicine in the United States and to restrict the individual rights of physicians and patients to seek the medical care that they consider most appropriate for their practices and good health.
This Web site is presented by Americans for Free Choice in Medicine. As the site expands, we will present information and reasoning from a number of non-profit organizations that share an interest in these issues. Each contribution will provide a link back to the organization that provided it, and readers of these pages are encouraged to seek further information from these organizations.
Within the general scope of the purpose of this site, there may exist a range of opinion. The views of each organization are their own, and participation in the content of this site does not imply agreement with all of the points of view that are expressed.
"You can't handle the truth!" That's the federal government's latest message to Americans seeking to learn the content of their own DNA.
Although this op-ed focuses on a seemingly narrow concrete (i.e., the FDA's new restrictions on direct-to-consumer genetic testing), Paul Hsieh, MD, of Freedom and Individual Rights in Medicine (FIRM), uses this concrete to show how apparently small regulations can have a major impact on Americans' lives — as well uses it as a springboard to discuss broader themes of free markets vs. government regulations, paternalism vs. individual responsibility, and the virtue of pursuing one's rational self-interest.
A recent research report by the Pacific Research Institute (PRI) reviews three decades of the Food and Drug Administration's performance and concludes that the agency is overfunded, overstaffed, and denies hundreds of thousands of Americans timely access to new medicines. Leviathan's Drug Problem: The Cost of the Federal Monopoly of Pharmaceutical Regulation and Its Deadly Cost was authored by John R. Graham, Director of Health Care Studies at PRI.
Eleven ways the FDA threatens or does real harm to our health:
The FDA adds billions to the development cost and price of new drugs.
The FDA delays the availability of new drugs for years.
The FDA prohibits the use of new drugs that treat conditions for which other drugs are available, regardless of how much better they might work for some patients.
The FDA withholds new drugs—even those that passed initial safety tests—from terminally ill patients, in the name of preserving safety. When one of these patients wins access to the drugs by going to court, the FDA, apparently in a relentless effort to protect the health of the dead, appeals the ruling until the patient dies, at which time the appeal is of course dismissed.
The FDA and Congress allow the drug approval process to be politicized to protect the interests of firms with political pull or to serve the anti-corporate political agenda of those who would rather see Americans die than allow any investors or businesses to make money developing new medications. Read more: Testimony at an FDA Hearing by Americans for Free Choice in Medicine
The FDA suppresses off-label use of drugs with proven ability to treat other conditions and restricts the circulation of information about such successful off-label use of drugs that have already been approved as safe. Read more:
By insisting that your own stem cellstaken from and returned to your own bodyare chemicals subject to regulation and standardization, the FDA expands its power to approve each individual treatment or procedure. This is a devastating restriction to all stem cell therapy. The same reasoning would effectively eliminate all personalized medicine based on individual genetic profiles.
The FDA actively seeks to extend the authority it so ineptly applies to drugs—and for which it asserts to have insufficient staff—to controlling all vitamins and food supplements. Whenever the reach of the FDA exceeds its grasp, it always tries to extend its reach. Read more: Get Ready for the Vitamin Police
The FDA constitutes a roadblock to new developments in anti-aging drugs by refusing to consider any science that would extend healthy lifespans—because "aging is not a disease."
The FDA states that it lacks the resources to ensure human drug safety but requests more resources to review veterinary medicine.
The FDA now publishes lists of drugs it approved but the safety of which it questions—leaving physicians in the lurch and creating a potential jackpot for litigation.