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On December 11, 2014 FDA published in the Federal Register a notice about proposed changes in the MedWatch forms (3500A and B) for post-marketing SAE/AE reporting.

The changes are largely cosmetic, though there is some increased collection of ethnic subgroup information. The proposed changes are detailed below.

First, however, FDA reviewed the report requirements for SAEs and those are worth reviewing here:

Voluntary Reporting

AE reports are not required to be submitted by health care professionals (HCPs) except for certain vaccine ARs. Vaccine reports are submitted on the VAERS form not on the MedWatch form. See the VAERs site for more information.

Hospitals similarly are not required to report AEs associated with drugs, biologics or special nutrition products but do have to report certain medical device-related deaths and serious injuries.

Dietary supplement manufacturers, packers, or distributors whose name appears on the label of a dietary supplement are required to report SAEs to the FDA. However, consumers and HCPs do not have to report SAEs, AEs or quality problems. Reporting can be by paper MedWatch forms or electronically.

MedWatch forms may be used for drugs, non- vaccine biologics, medical devices, special nutritional products, cosmetics, and non-prescription (over the counter (OTC) human drug products marketed without an approved application.

MedWatch Form 3500B Voluntary Reporting

The public is encouraged to report “negative side effects of prescription drugs to the FDA”. This wording is required in direct-to-consumer advertising. Voluntary reporting is done on the MedWatch 3500B form. This form is used for AEs, product problems and product use errors with drugs, non-vaccine biologics, devices, special nutritional products, cosmetics, non-prescription OTC drugs, tobacco products and dietary supplements. It is available electronically and on paper and may be mailed or faxed to FDA.

Mandatory Reporting on the MedWatch 3500A Form

Sponsors must submit AEs to the FDA. They are usually submitted on MedWatch Form 3500A or on CIOMS I forms (for ex-US serious, unexpected AEs). Electronic submission of such cases has been accepted by FDA for several years for post-marketing reports. Beginning on June 9, 2015, most post-marketing expedited reports (including OTC reports) must be submitted electronically. Full details available here.

Note that this does not apply to expedited IND reporting (SUSARs) but does apply to OTC products without NDAs or ANDAs.

Changes to the MedWatch Form

The changes proposed are largely formatting though some new data is now being requested.

Section A2 on patient age will now have check boxes for years, months, weeks and days. Section A4 on weight will now have check boxes for pounds and kilograms. Dates will be done in the DD-MMM-YYYY format. A watermark will be added to the date fields prompting the writer to use this format. This date format will also apply to fields B2 (Death), B3, B4, C (Returned to Manufacturer On), D7, E4 (Expiration Date), E6, and E7.

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A more substantive change will now be made based on the Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity, and as part of FDA’s Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.

Race will be deleted from field B7 (Other Relevant History”) though the field will remain for other information including pre-existing medical conditions. A new field in Section A on Patient Information (as above) will be added. This will be an ethnicity field, numbered 5a, and will include “Ethnicity (Check single best answer)” with corresponding check boxes for “Hispanic/Latino” and “Not Hispanic/Latino.” Adjacent to this field, the “Race” field will be numbered 5b and state “Race (Check all that apply).” It will contain check boxes for “Asian,” “American Indian or Alaskan Native,” “Black or African American,” “White,” and “Native Hawaiian or Other Pacific Islander.”

Other changes will be to the location, formatting and labeling of fields on the suspect product. Sections C & D on the current form will be merged into a single section entitled C “Suspect Products”. Currently C covers drugs/biologics etc. and D covers devices.

In the new section C, field C1 will be used for “Name and Strength,” “Manufacturer/Compounder,” “Lot #,” and “NDC # or Unique ID #” for up to two suspect medical products. Fields for “Lot #” and “NDC # or Unique ID #” on the current form (D6 and D9) will be removed on the proposed form. The single field for “Product Availability” (section C on the current form) will be relocated to C2 on the proposed form, immediately following the field for product name, strength, manufacturer/compounder, Lot #, and NDC/Unique ID #. As a result of sections C and D being merged, the remaining sections on the form will be changed (i.e. section E currently labeled “Suspect Medical Device” will become section D with the same label, section F will become section E, and section G will become section F).

On the 3500A form for Manufacturers, section C, field C1, “Name (Give labeled strength & manufacturer/labeler),” can also be used to request data for “Lot #” and “NDC # or Unique ID #.” Section C, field C1 will be relabeled “Name, Manufacturer/Compounder, Strength.” Proposed field C1 will contain distinct areas for “Name and Strength,” “Manufacturer/Compounder,” “NDC # or Unique ID #,” and “Lot #” for up to two suspect products. Since the information will now be captured in proposed field C1, separate fields for “Lot #” and “NDC #/Unique ID #” (C6 and C9 from the current form) will be removed. It is also proposed that a new field be added, numbered C2, and containing the descriptor “Product Available for Evaluation?” with check boxes for “Yes,” “No,” and “Returned to Manufacturer on (DD-MMM-YYYY).” Consequently, the currently numbered field C2, “Dose, Frequency & Route Used,” will be renumbered C3. Further changes will be made to the areas for dose, frequency and route. Numbering of fields C4 and C5 will change.

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Changes for Compounders and OTC Products

In addition to these changes, FDA has the authority to receive AEs from compounding facilities. These facilities will now have the same mandatory reporting responsibilities that manufacturers/sponsors have. Thus several fields where the word “Manufacturer” is used will now be changed to include “Manufacturer/Compounder”. Another change will be the addition of a new field to the “Suspected Products” section asking: “Is Product Compounded or Over-the-Counter? (Check all that apply)” with room for two products.  These changes will be made on both the voluntary and mandatory MedWatch forms.

The MedWatch form will still be three pages (or more if additional continuation pages are used). The instructions for filling them out will also be modified. It can be mailed into FDA as a self-addressed, postage-paid return mailer on the other side page one. Page three is a continuation sheet for the previous fields.

Privacy Disclosure

Most interestingly, the last field of Section E is changed from: “May we give your name and contact information to the company that makes the product (manufacturer) to help them evaluate the product?” to “If you do NOT want your identity disclosed to the manufacturer, place an ‘X’ in this box.”

This basically says that this information will be disclosed to the manufacturer unless the reporter specifically says NO.

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Unfortunately, FDA did not publish a mock up of the new form which would have made these changes much easier to visualize.

For further details, you should read the Federal Register notice.


These changes are largely superficial and are intended to allow easier data entry which, FDA hopes, will increase the information given on the form for each report. The ethnicity information is also somewhat more complete. The big change has to do with SAEs on compounded products. This is in response to the issues over the last two years with safety issues in compounded pharmaceutical products done at individual pharmacies. The change to the privacy statement is also interesting and it is likely that more cases will now be able to be made public from FAERS and FOI.

Since the FDA is requiring obligatory electronic SAE reporting starting in June 2015 as opposed to the current voluntary electronic reporting option, the use of the 3500A forms by industry will likely decrease markedly and ultimately disappear for post-marketing reporting. However, clinical trial IND safety reports must still be sent on 3500A forms or CIOMS forms. Consumer reports on the 3500B form will likely continue for some time.

The issues for industry are to be sure to both move to electronic reporting if it is currently done by paper and to be sure that you use the latest MedWatch 3500A form.



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