FDA drug summaries: a simplification too far?

Response: FDA Drug Summaries: A Simplification Too Far?

Doshi highlights some of the shortcomings of the FDA’s new Drug Trials Snapshots database to provide drug safety and efficacy information in consumer friendly language and certainly as he correctly notes it can be improved.[1]

However, Doshi is incorrect that Drug Trials Snapshots is the first time FDA history the agency has or has attempted to ensure that consumers have access to drug safety and efficacy information written in plain language. Consumer access to useful scientifically accurate drug information in the US has been a politically charged convoluted and contentious story over the last 45 years.

In the 1970s, groups representing women advocated for plain language information about the risks of combined oral contraceptives. Regulations were implemented that required the FDA to write such information and that it be distributed with each prescription for an oral contraceptive.[2,3] In the late 1970s, the FDA proposed a rule that for a limited number of drugs plain language patient package inserts be distributed with each prescription for one of these drugs. The patient information was based on the drug’s approved professional product label.[4] This rule was met with a firestorm of opposition and was withdrawn in the first days of Ronald Reagan’s administration.[5] The FDA Commissioner who advocated for patient package inserts was banished to the basement of the agency’s Parklawn Building without a telephone.

In the mid-1990s, then Commissioner David Kessler proposed the Medication Guide rule that would require the distribution to patients at the pharmacy of FDA approved risk information written in plain language for drugs that present significant public health concerns.[6] This rule also met with stiff opposition. The FDA persevered and now there are over 200 drugs that are required to be dispensed with Medication Guides.

In addition to the above there are an unknown number of drugs that the FDA has requested manufacturers or manufacturers have voluntarily provided plain language patient information as part of the professional product labels for their drugs.

The FDA could do a better in promoting what drug information is available on its and other government web sites for consumers. Healthcare journalists could play a more important role when writing about drugs to encourage patients to access FDA information, particularly safety information, before they fill a prescription for a new drug and explain to patients what this information is how to use it.

There are also deficiencies in the drug fact boxes promoted by Woloshin and Schwartz. Doshi includes a drug fact box for the hypnotic Lunesta (eszopiclone). The efficacy information presented is very useful. The safety information may be considered incomplete. Lunesta requires a Medication Guide that contains more complete information than that contained in the drug fact box. Also, the Medication Guide informs consumers of the serious adverse effects of the drug and what steps to take should these adverse effects develop.

Doshi apparently recognizes, as do Woloshin and Schwartz, the value on the publically available FDA analyses of data submitted by manufacturers in support of new drug approvals. These analyses are under utilized and their use is long overdue. To the best of my knowledge, for years only four publications have, or are now using, these FDA documents as sources of unpublished clinical trial data and two of the four are written specially for consumers.

Useful scientifically accurate drug information for patients is evolving and it can be argued in the right direction. Consumers do have a need and right to this information.

References

1. Doshi P. FDA drug summaries: a simplification too far? BMJ 2015;350: h3135.

2. Patient package inserts for oral contraceptives, 21CFR Sec. 310.501.

3. Curran WJ. Law-medicine notes. Package inserts for patients: informed consent in the 1980s. N Engl J Med Dec 24 1981;305(26):1564-1566.

4. US Department of Health and Human Services, Food and Drug Administration. Prescription Drug Products: Labeling Requirements. Federal Register Vol. 44:40016, July 6, 1979.

5. Pines WL. A history and perspective on direct-to-consumer promotion. Food Drug Law J 1999;54(4):489-518.

6. US Department of Health and Human Services, Food and Drug Administration. Prescription Drug Product Labeling; Medication Guide Requirements. Federal Register 1995: 44182-44252.