FDA to push drugmakers to provide latest drug safety information electronically

fda logo FDA to push drugmakers to provide latest drug safety information electronicallyPharmaceutical companies must provide health care providers with the latest available drug safety information via real-time electronic updates, according to a new rule proposed by the Food and Drug Administration (FDA).

“This would ensure that the most up-to-date version of the prescribing information is available to health care professionals and the public,” the rule states.

The new guidelines require drug makers to include a link on their drugs’ safety labels and outside packaging of the products that connects directly to a publicly accessible online repository with the drug’s most current instructions, including dosage recommendations, adverse events, and contraindications or drug interactions.

The new rule requires pharmaceutical companies to stay vigilant with their drugs’ repository listings and to alert federal drug authorities immediately of any changes to the drug’s safety label that are not yet on the site.

Drug companies must also include a toll-free telephone number be included on the drug’s container that can be used by physicians who do not have internet access. The new rule exempts inserts and medical guidelines for patients and any labeling on promotional materials.

The new regulation is expected to save the drug industry between $5 million and $74 million over a 10-year period, mostly from printing costs, the agency claims. However, pharmacies will have to shell out between $47 million and $89 million over 10 years for access costs, increased search time, and the printing of labels when requested.

The proposal will not go into effect until six months after the final rule is published. The new rule follows the agency’s final rule in June that requires most drugmakers including makers of over-the-counter drugs to report adverse effects electronically to help prevent delays in identifying new risks.

Source: Law360