For Healthcare Providers

The PI, or “Labeling Content” as it is called in legislation, is developed during the drug approval process. Once a drug has been identified as a candidate for market, it goes through three preliminary trail phases before the FDA approves it for release.

How the Package Insert (PI) is developed during the drug approval process:


Scientific Information Vs. 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.


How to Access FDA Approved PI Information

Internet search engines are not likely to get you to the official Package Insert, with copy reviewed and approved against clear, scientific criteria by the FDA. A number of pages or entries into a search, marketing sites or offers of cheap Internet drugs will prevail.

Here’s how to get to the official version:

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Type the name of the drug in the search box (if you don’t have a name handy, try “Metformin” and then pick a version; note that the tab “Patient Package Insert” is active on Metformin, so you can see what information is intended specifically for patients there.

The names of these drugs are used simply as examples of how to navigate Daily Med. As you will see, there is seldom only one official Package Insert on the website, offering further opportunities for confusion.