FDA ISSUES CEASE AND DESIST ORDER AGAINST SANOFI, WATSON'S
The Food and Drug Administration (FDA) has ordered pharmaceutical company Sanofi Pasteur, Inc. and drugstore chain Watson Personal Care Stores (Phils.) to cease and desist from advertising, promoting and conducting immunization activities in Watson's drugstores and to show cause why administrative and criminal charges should not be filed against them for conducting such activities without FDA authorization.
FDA Director General Nela Charade G. Puno said that the FDA has not issued any authorization to allow immunization community-based health services to be conducted by Sanofi, Watson's or any drug store.
"As such, there is no assurance on the safety and quality of the service rendered in these drugstores and thus poses a potential health hazard to the consuming public." Puno pointed out.
"Laws are mandatory and they are meant to be followed. Compliance to the law is not optional, especially when the safety and health of the public are involved. Sanofi, Watson's and other manufacturers and drug stores are hereby warned. Nobody is exempt." Puno said.
Puno said that they will ask Sanofi to explain why they violated the law for the second time, and if the FDA is not satisfied with their explanation, the FDA will be compelled to suspend or cancel its CPR for the said vaccine.
it will be recallled that last December 2016, the FDA also isued a cease and desist order against Sanofi for unauthorized promotion of its Dengvaxia vaccine. An admin case was also filed as a result.
"Nobody is above the law. If Sanofi continues to wantonly disregard the law, the FDA is authorized legally by virtue of RA 9711, to suspend or cancel the CPR." Puno said.
"We advise the public not to avail of these unauthorized drug- store initiated activities." Puno further warned.
In an advisory to the public, the FDA also ordered all concerned drugstores from conducting such activities until proper regulation and appropriate authorization have been issued. "Regulation action and sanctions shall be strictly pursued in case of non- compliance," Puno warned.
Puno also requested Local Government Units (LGU) and law enforcement agencies that these unauthorized activities are stopped in their respective jurisdictions.
In early April, FDA's Center for Drug Regulation and Research (CDRR) has monitored the unauthorized advertisement and promotion of Dengue vaccines. It was noted that Watson Personal Care Stores (Phils.), Inc., one of the country’s biggest drugstore chain, plans to distribute and administer Sanofi’s Dengue Vaccine (Dengvaxia) to potential clients.
Aside from the misleading promotion of the Dengue Vaccination Program which claimed it is now available over the counter, the ad image also showed a child less than 9 years old. (Dengue vaccine is approved only for 9-45 years of age.) It is also classified as a prescription drug. RA 9711 prohibits promotion of such without the authorization of FDA.
If a drug store wants to undertake additional services such as vaccination, it must apply for variation of its license to operate (LTO) from FDA.
Puno pointed out that several safeguards must be put in place prior to the conduct of drug store initiated immunization program. These are: qualification of the person administering the vaccine, dedicated space, sanitation, patient counselling among others.
Meanwhile, Puno said that the FDA and the Department of Health, in collaboration with the Philippine Pharmacists Association (PPhA) plans to train and authorize FDA-licensed community pharmacists to administer adult vaccines and other immune-products. Pharmacists are required by law to hold a certificate of training issued by an institution authorized by the Professional Regulatory Commission (PRC).
"We want to help broaden the availability of health services to our countrymen without compromising health and safety." Puno said.