In June 2014, the Food and Drug Administration (FDA) proposed a guidance that would give drug companies free rein to tell doctors that a medication is less dangerous than the FDA has concluded. If this guidance is finalized, companies would be allowed to inform health care providers — through medical journal articles and discussions with doctors — that the FDA-approved labeling overstates a medication's risks. Under the guidance, the FDA "will not object" to this misrepresentation of a...
In June 2014, the Food and Drug Administration (FDA) proposed a guidance that would give drug companies free rein to tell doctors that a medication is less dangerous than the FDA has concluded. If this guidance is finalized, companies would be allowed to inform health care providers — through medical journal articles and discussions with doctors — that the FDA-approved labeling overstates a medication's risks. Under the guidance, the FDA "will not object" to this misrepresentation of a drug's safety.
The guidance was subsequently open for public comment. Two strikingly frequent themes emerged from the 1,771 comments opposing the guidance, which amounted to 99 percent of all those filed.
Some viewed the proposal as FDA-encouraged drug industry interference with the doctor-patient relationship. About one-third of the commenters explicitly referred to their personal doctor-patient relationships, with statements such as "I oppose the FDA proposal to let Big Pharma push information on my doctor that contradicts government-approved warning labels" and "If drug companies can tell my doctor that a medication is safer than the FDA says it is, what is the FDA for?"
A related theme involved a widespread and increasing distrust of the FDA for proposing the guidance. A physician wrote: "I am beginning to wonder about the FDA. I always thought the purpose of the FDA was to put out reliable information — 100% trustworthy, at least so far as current scientific knowledge is concerned. This proposal has shaken my confidence in the FDA. The FDA is not supposed to be working for the pharmaceutical industries!"
Other comments filed, from people with a variety of backgrounds, further elucidated the serious problems with the guidance:
- "As an old retired FDA' er I'm really insulted if you are actually considering allowing the Drug Industry to provide information of safety INSTEAD of your information. I saw the [industry's] attempts to influence regulations to their benefit while I was there nearly 30 years and I know you know better than I so why in the world would you ease your regulations in their favor? Please, stop any political influence in the essential work you have to do enforcing your/our [f]ood and [d]rug regulations."
- An anonymous comment: "Before my retirement I worked for over thirty years in the pharmaceutical industry and medical education and advertising agencies so I am very familiar with FDA regulations concerning promotion of approved prescription drugs. Pharmaceutical companies try to communicate the benefits of their products and minimize the risks. Limiting promotional claims to those supported by the approved label is one way to safeguard patients. I am opposed to the industry being permitted to distribute literature that makes safety claims not supported by the approved label."
- "It is unbelievable that consumers have to ask the FDA to prohibit pharmaceutical companies from telling my physician that drugs are safer than the FDA says they are. Do I as a taxpayer pay the FDA or have the drug companies taken over the entire system. This is unbelievable."
- One physician wrote: "Relaxing the process for approving new medications and giving less information to the public and healthcare providers does not seem wise or in the best interest of the public. Drug reps stretch the truth more than enough. It isn't a good idea to give the drug companies even more latitude or to buy their way to [the] head of the line."
- Another wrote: "As a physician and as a patient I am appalled at the prospect of allowing drug companies to tell me that a drug is safer than what FDA's assessment and expert committee analysis determines. It's bad enough that we are barraged by direct drug company to patient advertising. To allow the drug companies to misrepresent the true safety issues of their product would be unconscionable."
- And a nurse: "This proposed regulation appears to be protecting the pharmaceuticals['] interests and reducing the protection for patients from risks of prescription drugs and biological products. More and more drugs are showing negative effects with longer usage. More reporting of risks over time are needed, not less. I am very concerned about the proposed relaxation of regulations that [allow] the pharmaceutical companies to self-promote off-label uses without proper peer review. Peer review is essential for protections of consumers."
- A pharmacist: "It is time for the FDA to step up and do its job. I am a retired pharmacist at the age of 74. I retired mainly because I no longer trust [p]harmaceutical [c]ompanies to give me accurate information on drugs or the FDA to guarantee a proper drug."
- "As a [government-employed] physician, I strongly oppose letting pharmaceutical companies directly give information to doctors that may contradict the information published in scientific studies. There is already ample information [that] pharmaceutical companies in the past have pushed drugs where the scientific data was weak or even absent. The last thing the FDA should do is encourage this sort of unethical behavior."
- "As a former reviewer at the FDA, I know the twist that industry puts on the scientific findings of their drugs. It comes very close to lying and I know their drug reps are even worse — There is no way the busy physicians could get an unbiased review of drug data by the drug reps. … This must not be allowed!!!"
Since the FDA is legally the government shield against drug industry efforts to market products that may not have a favorable ratio of benefits to risks, many commenters recognized that giving companies a green light on this issue could distort the benefit-risk balance established through the new drug application review process in a manner favorable to drug companies, but arguably dangerous to patients.
If there is evidence that after approval, a drug appears to have fewer risks — which happens extremely rarely — the remedy is to have companies comport with, rather than undermine, FDA laws and regulations. The manufacturer should send the evidence to the FDA, state the basis for the reduction in risk and request a labeling change.
Public Citizen has urged Secretary of Health and Human Services Sylvia Mathews Burwell to withdraw this dangerous “risk reduction” proposal.
Let us help you contact your representatives and senators in Congress to urge them to request that the FDA withdraw this dangerous proposal. You can send a statement to your House representative and senators by visiting www.citizen.org/FDA-no-caving-on-drug-safety. With enough pressure from Congress and the public, the agency will have no choice but to retract its harmful guidance.