Pharmaceutical Companies and Medical Device CompaniesWhat is reported:
Companies are required to file:
- Notice of Meetings/Symposia
- Post Travel Report
Relevant quotes from the Order:
“The sponsoring PPPMD company, through its Medical Director, shall submit through the FDA website, events involving local and foreign travel containing the following information (Annex A):
- The purpose/objectives of the travel, including the name, organizer, description, location and date of event;
- The scope and estimated value of sponsorship to the event shouldered by the PPPMD company;
- If the recipient is employed by the government, the sponsored HCP shall make a post travel report to his respective agency, including appropriate recommendations. Travel of government employees shall be in accordance with pertinent rules and regulations regarding such; and
- The sponsorship for travel of HCPs attending events as legitimate participants shall only be for Economy class unless otherwise justified by health reasons or special needs of the HCP.”
“PPPMD companies shall inform the FDA of any activities/events undertaken by the said company, whether or not the activities are in conjunction with any medical society/association, at least one month prior to holding of the said activity, if the activity involves more than 100 HCP participants. This is in order to enable the FDA to observe and monitor compliance with these guidelines.”
“The FDA designated or authorized officer and/or staff shall be allowed to do unannounced monitoring visits at conventions, symposia and conferences utilizing FDA funds”
See full text in the link to the Order at Resources.
*“This Order shall apply to all natural and juridical persons and entities engaged in the dissemination or publication of information, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities of prescription pharmaceutical products and medical devices including their agents and/or their industry association.”
- This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
- Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information provided reflects the most recent changes and is still applicable.
- Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding – in most cases – suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. In case it is based on codes of conduct, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of the association that follows that code.
- Including a jurisdiction in the Legislative Watch does not guarantee that jurisdiction is available for reporting via the MediSpend Transparency Reporting Solution.
- Reporting date normally means the date the transfers of value need to be published. The deadline for e.g. submission/sending the complete information to the authority could be before that date, for example to give HCPs and/or HCOs and/or the authority/association who publishes the information, the possibility to check the data the pharmaceutical companies/medical device companies are going to disclose.
- The information does not take into consideration (unless explicitly mentioned):
- Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
- Transparency related to patient organizations (unless the patient organization is considered an HCO)
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