Senator Rick Scott of Florida introduced the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (Clear Labels Act), which “would require prescription drug labeling to disclose the original manufacturers of generic drugs and APIs, giving patients, providers, and regulators clear, upfront information about a drug’s origins.” According to his website (here), “Many prescription drugs, and their active pharmaceutical ingredients (APIs), are manufactured overseas, particularly in Communist China and India, and current federal labeling requirements do not require public disclosure of where those ingredients or finished products are made.”
While we haven’t been able to locate the text of the bill, it appears that the labeling of prescription drug products is likely to get even more crowded. While this is information that should be available to consumers and healthcare professionals, there will likely be an increased burden on pharmaceutical companies as they try to squeeze the information regarding the manufacturer, distributor, and source of the active pharmaceutical ingredients (APIs) on the label. Just imagine a drug product distributed by company X, manufactured by company Y, containing multiple APIs that are made by companies A, B, and C. While this might not be a problem for prescription bottles with large labels, it will certainly present a problem for small volume parenteral products and smaller prescription bottles.
The question may be how will the requirements of the Clear Labels Act ensure that the information will actually get to the patient? Slap a label on a small manufacturer’s 8- or 12-dram unit-of-use Rx bottle and the information might well be obscured, and if there is a different manufacturer and distributor for a product, especially those that contain two or more APIs (which must also be documented on the label, obviously). Right now, it’s difficult to even find that information on a unit-of-use manufacturer’s bottle with a prescription label attached.
While I believe that this information is both important and a step forward, the devil is always in the details. Will the pharmacist be required to include all of this information on a printed prescription label affixed to regular prescription bottle and not the original container? The nature of the supply chain could also cause the pharmacist a headache as different manufacturers for a given product come and go with changes in buying practices or supply contracts with distributors, which could require multiple changes in prescription labeling with each supplier change. Having practiced pharmacy and been in drug regulation at the FDA and in industry for over fifty years, I know that the pressure is on pharmacists, who are the ones actually filling prescriptions; I just hope, if this bill is passed, that there is considerable thought given to how it can be implemented without causing a problem for those who must ensure that the information is readily available to the patients.
