FDA orders pullout of Dengvaxia

MANILA, Philippines — To “protect the general public,” the Food and Drug Administration (FDA) has ordered the withdrawal from the market of anti-dengue vaccine Dengvaxia of France-based pharmaceutical firm Sanofi Pasteur.

In Advisory No. 2017-318 dated Dec. 4, FDA director general Nela Charade Puno said Sanofi Pasteur should “immediately… suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA.”

Sanofi was also directed to conduct an information dissemination campaign through “advisories, dear doctor letters and patient fora.”

The advisory was issued after Sanofi released an updated information last Nov. 29 that Dengvaxia could have “potential risk to patients who have not had dengue prior to immunization” based on a post-clinical trial study of the product.

Puno noted the FDA is closely coordinating with the Department of Health (DOH) for “any adverse events/reactions that may be reported by the recipients following their immunization of Dengvaxia.” 

She said the agency “will immediately take appropriate measures to protect the public.”

“Drug establishments, including consumers and non-consumer users (healthcare professionals), are enjoined to take part in the post marketing surveillance of Dengvaxia,” Puno said.

She added that the public can report to FDA “any incident that reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness or serious injury to a consumer, a patient or any person.”

Senators demand payback, probe

Senate President Pro Tempore Ralph Recto urged the DOH to demand a refund from Sanofi as Dengvaxia could be considered faulty or ineffective.

In a statement, Recto pointed out that Republic Act 9184 or the Procurement Law provides what could be considered as a “warranty” for purchases made by the government.

“RA 9184 has an anti-lemon provision. It is discussed extensively in Section 62, which deals with faulty, defective, substandard goods and services. The bottom line is that the government is entitled to restitution,” Recto said.

“In fact, RA 9184 requires the supplier to post retention money, which the government shall hold on to until the warranty has lapsed, to ensure that goods supplied are free from defects,” he added.

In this particular case, Recto said the DOH could demand a reimbursement for the purchase of Dengvaxia, which was pegged at around P3.5 billion to P4 billion.

“If something is purchased such as medicine, which cannot be replaced because there is no substitute, then government can demand reimbursement,” Recto said.

According to Recto, if Sanofi refuses to acknowledge the demand for reimbursement, the Procurement Law provides that “its properties shall be subject to attachment or garnishment proceedings to recover the costs.”

“The no return, no exchange policy does not apply to government purchases,” Recto said.

Under RA 9184, even official supplies, car parts and appliances bought for government must pass the quality test.

He noted that many big companies have already paid huge fines based on the orders of government regulatory bodies.

“Uber, Metrobank, RCBC, PAL are some of the companies which have willingly paid a fine or settled obligations for operational oversights committed,” Recto said.

On the part of Sen. Francis Pangilinan, he said it would be prudent to wait until more information about the alleged adverse effects of the vaccine before taking legal action against any party involved in the procurement and distribution of the drug.

“It is better to listen and get information from the World Health Organization and other countries that approved the use of this vaccine. These would be Singapore, Thailand, Indonesia, Mexico, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala and Peru,” said Pangilinan.

“Did their citizens experience adverse effects from the vaccine? Was the vaccine also questioned in their countries? Are they holding their officials accountable?” he added.

“Once the independent expert opinions are in and there is proof showing that some fell short, then we hold to account those who were negligent and failed to conduct due diligence,” said Pangilinan.

“Let us first listen to independent health experts before we judge. If lawyers have their own individual interpretations of the law, the same is true of the medical community, which will have different opinions on this health issue,” Pangilinan said.

He pointed out that the program was implemented by the DOH during the last year of the Aquino administration and continued by the Duterte government, upon the recommendation of the new DOH leadership.

Sen. Paolo Benigno Aquino IV said aside from digging deep into the controversy, concerned government agencies must monitor the status of students who received the initial dose of the vaccine to ensure their health and wellness.

“What’s important is that the condition of those who received the vaccine is monitored,” Aquino said.

Senate Minority Leader Franklin Drilon said Sanofi, together with the government, has the duty to ensure the safety of those vaccinated.

“As what the health experts say, dengue kills. And it is the responsibility of government to find a safe and effective solution to the disease,” Drilon said.

Sen. Joseph Victor Ejercito, chairman of the Senate committee on health, said he will request Sen. Richard Gordon to move the inquiry into the dengue vaccination program.

Gordon, chairman of the Blue Ribbon committee, had scheduled a hearing on Monday that is supposed to be held jointly with Ejercito’s panel.

Ejercito said it would be better if WHO officials would be invited to the inquiry and for the DOH to be given a little more time to gather information on the matter before the hearing.— With Marvin Sy, Paolo Romero