By: Ma.Sophia Editha Cruz-Abrenica and Glaiza Narvacan
In an effort to warn against misinformation surrounding the coronavirus pandemic and pursuant to its mandate to protect and promote the right to health of the Filipino people, the Food and Drug Administration of the Philippines (FDA) released a number of issuances pertaining to COVID-19. A summary of the FDA circulars, advisories and press statement is provided below:
Donated Health Products
FDA Circular No. 2020-009 and its amendments[1] provides guidelines on the identification, notification, evaluation, regulatory enforcement action, and review and monitoring of donated health products solely intended to address the COVID-19 public health emergency.
The health products (whether locally or foreign donated) within the scope of this Circular as amended are as follows:
The guidelines within the Circular provide, among others, that the documentary requirements for donations provided in DOH Administrative Order No. 2007-0017 shall be received by the Food and Drug Center (FDAC) for notification purposes. Once the complete set of documents has been received from the DOH, the donated covered health products are immediately deemed cleared. Nevertheless, the FDA will still subject the donated products to post-notification evaluation and further regulatory or enforcement action.
This Circular, which was originally in effect until 30 May 2020 only, is now in effect until 31 August 2020.
Advertisements for Food Products, Food Supplements, Medical Devices, Disinfectants and Biocides Pertaining to COVID-19
In FDA Advisory No. 2020-531[2], the FDA warns the public against unapproved and misleading advertisements and promotion of various food products and food supplements that claim to boost immune system and decrease the risk for coronavirus disease. The FDA states that “[f]ood products and food supplements shall not, in any way, prevent, cure and especially reduce the risk of COVID-19 and any other diseases, and should not bear any misleading, deceptive, and false claims on their labels and/or any promotional materials that will provide erroneous impression on the product’s character or identity”.
Likewise, in FDA Advisory No. 2020-782[3], the FDA warned the public against unapproved and misleading health claims of medical devices such as face masks. It reminds the public that “Ear loop facemask shall not, in any way, cure and specially kill viruses and bacteria like influenza A and SARS and any other diseases, and should not bear any misleading, deceptive and false claims on their labels and/or any promotional materials that will provide erroneous impression on the product’s character or identity”.
In its Advisory No. 2020-852[4], the FDA issues another warning against misleading advertisements, promotion and claims on safety and effectiveness, this time, of various disinfectants/biocides, and advises the public to be vigilant against deceptive promotion and marketing of these products. Further, the FDA warns that exposure to ingredients such as chlorine dioxide or chlorite through inhalation and skin contact may cause irritation in the mouth, esophagus or stomach, shortness of breath and other respiratory problems.
The FDA advises the public to be vigilant against such deceptive marketing and emphasizes that as of this time, there are no specific vaccines or treatments for COVD-19. It further encourages the public to follow health advice and guidance from the Department of Health (DOH) and the World Health Organization (WHO) on protective measures against COVID-19. Finally, the FDA gives a stern warning to all Market Authorization Holders of food products and food supplements and medical devices to stop misleading advertisements and promotions. The FDA shall execute appropriate regulatory tools and sanctions to companies that will continuously conduct such and other similar activities.
Warning on Drugs and Vaccines with Unproven Claims for COVID-19 Treatment
In a Press Statement[5], the FDA reminds the public once again that there are no registered drugs or vaccines that are licensed specifically for use in COVID-19 treatment or prevention, and warns the public regarding the use of drugs or vaccines with unproven claims of safety and effectiveness in relation to the COVID-19 disease.
The Press Statement also mentions that there are ongoing clinical trials to investigate the safety and efficacy of new and existing drugs for COVID-19, one of which is the Solidarity Trial launched by the WHO, which is a large-scale trial having many countries as participants including the Philippines.
The FDA also clarifies that drugs and vaccines must be registered with the FDA Center for Drug Regulation and Research (CDRR), and until products are proven safe and effective for use as treatment, they cannot be dispensed to the public nor can therapeutic claims be made.
Access to Vitamin Products During the Covid-19 Pandemic
FDA Circular No. 2020-15[6] relates to interim measures to ensure access to vitamin drug products during the coronavirus pandemic. All locally manufactured and imported bulk registered vitamin drug products for packaging/repacking under the Household Remedy (HR) and Over-the-Counter (OTC) classification are covered by this Circular.
The Circular, which shall take effect for the duration of the declared quarantine only, provides guidance for the 1) initial registration of vitamin drug products of alternative packaging relative to its currently registered counterpart; 2) temporary marketing authorization of vitamin drug products with different blister or capsule color; and 3) temporary marketing authorization of vitamin drug products without secondary packaging, but rather through bundling.
Special Permit for Loaned Mobile X-Ray Devices During the COVIC-19 Pandemic
Following the increase in the demand for X-ray devices for the diagnosis of COVID-19 and the delay in the delivery of mobile X-ray devices which were newly purchased to meet the increased demand, the FDA in Advisory No. 2020-744[7] informs all medical radiation facilities such as local government units (LGUs), government owned or controlled corporations and other government instrumentalities, that the Center for Device Regulation, Radiation, Health and Research (CDRRHR) through the Radiation Regulation Division (RRD) shall be issuing a Special Permit for loaner unit mobile x-ray devices, intended for use in the diagnosis of patients in urgent need of imaging procedures and medical response.
The Advisory, which took effect on 14 April 2020, provides for the requirements, as well as the guidelines, for the Special Permit application. Among the notable provisions is that the processing of the Special Permit shall be exempted from payment. Once the newly purchased X-ray device has been delivered and installed, the facility shall apply for issuance of appropriate authorization.
Customs Release of Respiratory Therapy Devices
In FDA Advisory No. 2020-761[8], the FDA informs the public that importers of Respiratory Therapy Devices (RTD) need only to present copies of their License to Operate prior to customs release. In addition, foreign donations of RTDs to be used in treating COVID-19 patients do not require clearance from FDA prior customs release. These procedures shall remain in effect until otherwise lifted.
Price Ceiling on Medicines and Medical Devices
Circular No. 2020-017[9] relates to the prohibition on the selling of essential emergency medicines and medical devices beyond the price ceiling or range set by Department Memorandum No. 2020-0058 issued by the DOH which declared a price freeze on essential emergency medicines and supplies in the Philippines in response to the Covid-19 pandemic.
The FDA also encourages the public to check the authorization status of establishments and health products at the FDA website, www.fda.gov.ph. Further, FDA Advisory No. 2020-422 pertaining to “Updated List of Notified Hand Sanitizers and Registered Topical Antiseptics and Antibacterials” can likewise be referred to.
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This article is intended for informational purposes only and should not be considered as legal advice.
[1] The links to the Circular and its amendments are as follows:
https://www.fda.gov.ph/fda-circular-no-2020-009-guidelines-on-the-identification-notification-evaluation-regulatory-enforcement-action-and-review-and-monitoring-of-donated-health-products-solely-intended-to-address/ [Last accessed 03 June 2020]
https://www.fda.gov.ph/fda-circular-no-2020-009-a-amendment-to-include-ventilatorsrespirators-and-their-respective-accessories-to-the-list-of-medical-devices-covered-by-fda-circular-no-2020-009/ [Last accessed 03 June 2020]
https://www.fda.gov.ph/fda-circular-no-2020-009-b-amendment-to-include-respiratory-therapy-devices-in-the-list-of-medical-devices-covered-by-fda-circular-no-2020-009-as-amended-by-fda-circular-no-2020-009-a/ [Last accessed 03 June 2020]
https://www.fda.gov.ph/fda-circular-no-2020-009-c-extension-of-effectivity-of-fda-circular-2020-009-entitled-guidelines-on-the-identification-notification-evaluation-regulatory-enforcement-action-and-review/ [Last accessed 03 June 2020]
[2] The full text of the Advisory can be viewed here: https://www.fda.gov.ph/?s=2020-531 [Last accessed 03 June 2020]
[3] The full text of the Advisory can be viewed here: https://www.fda.gov.ph/fda-advisory-no-2020-782-public-health-warning-against-the-unapproved-and-misleading-health-claims-of-medical-devices-that-decrease-the-risk-for-coronavirus-disease-covid-19-infection/ [Last accessed 03 June 2020]
[4] The full text of the Advisory is available here: https://www.fda.gov.ph/fda-advisory-no-2020-852-public-health-warning-against-the-purchase-and-use-of-disinfectants-biocides-products-with-misleading-health-claims-that-decrease-the-risk-for-coronavirus-disease-covid-1/ [Last accessed 03 June 2020]
[5] The Press Statement can be viewed and downloaded via this link: https://www.fda.gov.ph/fda-warns-the-public-on-drugs-and-vaccines-with-unproven-claims-for-covid-19-treatment/ [Last accessed 03 June 2020]
[6] The detailed guidelines as provided by the Circular can be viewed here: https://www.fda.gov.ph/fda-circular-no-2020-015-interim-measures-to-ensure-access-to-vitamin-drug-products-during-the-coronavirus-disease-2019-covid-19-pandemic/ [Last accessed 03 June 2020]
[7] To view the full text of the Advisory, click here: https://www.fda.gov.ph/fda-advisory-no-2020-744-advisory-for-the-issuance-of-special-permit-for-medical-radiation-facilities-using-loaned-mobile-x-ray-devices-during-the-covid-19-pandemic/ [Last accessed 03 June 2020]
[8] A copy of the Advisory can be downloaded via this link: https://www.fda.gov.ph/fda-advisory-no-2020-761-fda-clearance-of-respiratory-therapy-devices-prior-customs-release/ [Last accessed 03 June 2020]
[9] The Circular can be downloaded via this link: https://www.fda.gov.ph/fda-circular-no-2020-017-prohibition-on-the-selling-of-essential-emergency-medicines-and-medical-devices-beyond-the-price-ceiling-range-set-by-the-department-memorandum-no-2020-0058/ [Last accessed 03 June 2020]
