FDA CAN'T GUARANTEE DRUG SAFETY

FDA CLOUT DIMINISHED

The FDA controls market entry of drugs and the use of unsafe and unproven product.  It regulates 1 trillion dollars worth of consumer goods that is 25% of our economy.  It controls the food you eat, the drugs you take, the lipstick you use, the medical devices you use and the ones that are implanted in you.

The safety and integrity of all these consumer products are the responsibility of the manufacturer.  The FDA only provides a regulatory role.   Is this fair? 

  For the agency to function properly, Congress must adequately fund it.

The FDA takes on more and more responsibility without having its budget increased.  In the last 10 years the FDA cut its personnel ten percent.  The personnel left must work with inadequate technological information.  If has old computers, records stored on paper that cant be analyzed when and if they become accessible.

The FDA is using a risk-based method to choose where the problems are more likely and where inspections should be focused.  The FDA is simply overworked.  Inspections have dropped 60% in the last 25 years while facilities have increased. Eighty percent of our drug products are now made in China or India that have poor regulatory standards Many products are now made out of the country for the best price.  Science and business have changed, but not the FDA.

Melamine in pet supplies and contaminated heparin show clearly that the manufacturer must supervise things, inspect facilities and get verification.  The language barrier adds to the inspection problems.  Since the manufacturer wants the lowest cost supplies, it should be responsible to control the quality of its supplies. 

DRUG APPROVAL

The FDA controls the approval process by requiring substantial evidence that the drug works, is safe for specific clinical situations.  The approval is indication specific.  Once the drug is on the market the FDA plays a minimal role in its control.

Using a drug differently from what is approved by the FDA is now legal and very common.  It is done without supporting data and not evaluated formally.  This is called off label use.  What is good for one disease may be harmful to another.

Everyone has a say in how the drug is used and who will pay for it. Insurance companies, the pharmacy industry, doctors and you the patient.  The FDA must balance these expectations.  It does so by regulating marketing on TV and in ads.  It uses its control by issuing guidelines.

HOW OFF LABEL USE  BEGAN

Presume a drug is in a class of drugs and its use is expanded to distant conditions.  If symptoms overlap, why not use it?  For example, antidiabetic drug metaformin, is used to treat polycystic ovarian disease.  Seroquel, an antipsychotic drug for adults, is used for depression in children. Singular, an antistatic drug, was used for chronic pulmonary disease.  Aspirin for diabetes is used to prevent heart disease.  Prograf, a drug for autoimmune disease, now is used for transplantation.  Neurontin, is used for painful diabetic neuropathy.  Why not use it for herpes zoster? 

 

Though these new uses could be added to the drug label through another new drug application, why bother?  Big Pharma can’t pay the expenses for costly clinical trials that might prove the drug does not work.  This off label using avoids a risky business decision and the FDA doesn’t care.

CONCLUSION

Products must to hold to high standards.  How can the FDA keep up with testing, if 90% of our finished drugs are make overseas by foreign drug manufacturers?

Congress has less money today to fund the FDA.  The FDA could charge the drug manufacturer fees to cover the cost of drug approval processes and charge for Drug reviews.  This would raise drug costs passed on to you. No drug trial will uncover all the drug risks.  You and your doctor should know the benefits anode risks of a drug and make up your mind.

Don’t ever believe that the FDA can guarantee a drug’s safety.  Because the FDA approved your drug, does not mean it is absent of any risk.   It is hard for the FDA to ensure every drugs safety. We taxpayers should not need to send inspectors to every factory in China and India.  With fewer dollars and resources, don’t blame the FDA if it can’t keep up with its role as our watchdog.

Companies try to increase their profits and your risk goes up.  As trials are shortened, studies are designed by the drug companies and funded by them; there is a greater responsibility to meet regulatory requirements. 

                  Source: NEJM April 24, 2008

 

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