PPLA - The Pharmaceutical Literature Association; We're fighting to keep medication information on paper - for patient health and safety

Scientific Information Versus Marketing

The Food and Drug Administration (FDA) criteria for information for professionals and patients starts with scientific accuracy presented without bias. Drug manufacturers are held to a high standard when the FDA reviews the Labeling Content, the written contents of the Package Insert. The FDA has provided clear directions on the content required, and the format for legibility and readability, including limits on how small the type size can be.

Cegedim Strategic Data reports that pharmaceutical marketing and promotional expenditures topped $27 billion in 2012. Type in the name of a drug in a search engine, and pages and pages of sites emerge immediately – and most of them are links for marketing sites, either for the drug itself or for other online healthcare services, most legitimate, some not at all. Here's a link to the World Health Organization that looks at the pharmaceutical industry worldwide.

The labeling copy is usually the last element the FDA approves when it approves a drug for “launch.” The FDA is not a rubber stamp in these negotiations, which are private. Many launches have been delayed because the FDA and the manufacturer could not agree on warnings, precautions or claims.

Consumer Medication Information (CMI) is completely unregulated in the U.S. The Package Insert is the only reliable source for scientific information about drugs. While it is written for healthcare providers, patients too can ask for the Package Insert at their pharmacy and receive a paper copy or they can review the FDA-approved, manufacturer-supplied, copy online.

The existing system of printed Package Inserts offers unbiased scientific information throughout the entire drug supply chain. Although not written for patients, but for healthcare professionals, the Package Insert is the primary source, sometimes through republication, of reliable, scientific information for healthcare professionals as learned intermediaries to patients, or for the involved patients who ask for and read the Package Insert themselves.