Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory
drug”. The reasoning is that if the reporter did not believe there was at least some level of association (causality) with the drug, he or she would not have reported it. This comes from an earlier CIOMS recommendation.
In 15 calendar days: Reports from the medical literature that are serious and unexpected.
In the quarterly or annual periodic reports (PADERs) or PSURs: A narrative summary and analysis of the 15-day alert reports submitted since the last periodic report plus all other reports that are not serious and not unexpected. Foreign non-serious AEs do not have to be reported. In general, clinical trial AEs do not have to be reported to the NDA. Note that, currently, ICH E2C PSURs are not required by FDA and PADERs are required by regulations. FDA does accept PSURs with the PADER-specific appendices; the ICH PSUR (PBRER format) may be made obligatory at some point in the future.
Solicited reports: AEs that are received from customer engagement programs with the possibility of two-way communication, e.g., disease management programs, patient support programs, etc., should be reported as 15-day reports to the NDA if they are serious, unexpected, and associated with the drug. It is the latter causality assessment that differentiates solicited reports from spontaneous reports (FDA Guidance for Industry, August 1997).
What is Expected from Consumers and Healthcare Professionals by the FDA?
Safety reporting by consumers and the healthcare community is purely voluntary, but strongly encouraged. (Exception: The US National Childhood Vaccine Injury Act (NCVIA) requires healthcare providers to report: (a) Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine; and (b) Any event listed in FDA’s Reportable Events Table that occurs within the specified time period after vaccination (see www.fda.gov for the latest Reportable Events Table).) Reports may be made to the FDA directly via MedWatch (mail, online, fax, etc.) or to the pharmaceutical company that manufactures, sells, or packages the product. Once a manufacturer (NDA holder or “Applicant”) or distributor, etc., learns of an adverse event for one of its products, reporting to FDA is mandatory.
FDA Publications and Updates
FDA has various publications and feeds freely available without cost online, such as e-mail alerts and as RSS feeds. “What’s New (Drugs)” comes out several times a week with new drug-specific information. The relevant publications are well worth receiving, particularly the MedWatch and CDER notifications.
Others include the following:
The reports may change from time to time, with new ones introduced and old ones phased out. Check the FDA web site for updates. There are other alerts on biologics, CBER, and specific diseases and conditions, including HIV and infectious hepatitis, women’s health, medical devices, research, food contamination, and cosmetics.
This site offers sign-up for multiple subscriptions at the same time from various health and human services agencies and divisions, including the CDC, NIH, Med-Line Plus, and others.
The FDA, the industry, and nearly everyone else is now struggling with the newly and rapidly arising social media (Twitter, Facebook, LinkedIn, Buzz, blogs, bloginars, eCards, podcasts, widgets, virtual worlds, etc.). As of this writing, FDA had several Twitter feeds and a Facebook page, and is expanding its use of social media.
The FDA’s influence on life in the United States is extensive. The Agency oversees and regulates drugs, biologics, vaccines, dietary supplements, radiation-emitting devices, certain foods, cosmetics, and tobacco. They cover both human and veterinary products. FDA’s influence outside the United States is obviously less strong than within the United States but, nonetheless, is felt through direct and indirect actions in international entities (e.g., ICH, CIOMS, where FDA is a major player either directly or indirectly), formal and informal interactions and memoranda of understanding with other health agencies (Europe, Canada, Japan, China, etc.), and as a thought and action leader (e.g., a drug safety restriction or withdrawal in the United States must be addressed, in practice, rather quickly elsewhere around the globe). FDA also has an extensive network of offices outside the US (Mexico City, San Jose, Santiago, London, Brussels, New Delhi, Beijing, among others).
For those in industries regulated by the Agency, the FDA has an impact on actions every moment of the day in just about all areas of business: