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New FDA chief initiates reforms

With most millennials opting for a healthy lifestyle, the food, cosmetics and drugs sector is witnessing robust sales and drawing a number of local and foreign manufacturing and trading companies.

Surging sales, however, do not guarantee quality and may harm the unsuspecting public if the government fails to effectively regulate the production and distribution of such food, cosmetics and drugs products.

The Food and Drugs Administration, as regulator of the products, must assume a proactive role to protect the interest of consumers and assure them their value for money. The new FDA chief so far has attuned herself to the nature of the sector. The  reforms she initiated in the FDA so far are paying off, despite a reported strong opposition from shadowy characters bent on perpetuating the old malpractices in the agency.

New FDA director-general Nela Charade Puno, after assuming office late last year, went to work right away In improving the agency’s internal systems. FDA is one agency that had stood on the way of the progress of the industries it regulates due to inefficient and tedious processes. Applicants for the registration of products, for instance, had to wait for a long time before getting the needed approval.

The slow process, perhaps, could be one of the reasons why unregistered food, cosmetics and drugs products had proliferated in the market. Many ran out of patience and decided to bring their products to the market sans an FDA seal of approval.

The problem at the FDA was a no-brainer. Puno ordered the speeding up of approval processes. She laid down policies on a 72-hour turnaround time and zero backlog goal. What this means is that applications should get either a nod or a no within a three-day period—not three months, not three years.

Puno also directed the FDA’s enforcement unit with the support of the Philippine National Police to step up the drive against counterfeit medicines, food and cosmetics.

Sources said Puno’s directives drew a vehement reaction from some quarters within the FDA and its mother agency, the Department of Health. This is understandable. It seems there are elements who make money from the turtle-paced processes and illegal products. Some really benefit from the misery of others.

These elements may have underestimated Puno’s resolve to make her agency more efficient. Despite the opposition from within, the industry she regulates has recognized the improvements she has made.

Industry support

Just recently, a big pharmaceutical association batted for the inclusion of the FDA in an inter-agency committee on generic drugs, whose creation has been proposed by the Board of Investments.

The proposed inter-agency committee will include the Departments of Trade, Health, Science and Technology and Finance, as well as the Intellectual Property Office. The FDA was not included in the initial draft and its involvement was supposed to be through the DoH.

The Philippine Chamber of the Pharmaceutical Industry called for giving the FDA a seat in the proposed inter-agency body, independent from the slot of the DoH. The PCPI said the FDA was “an indispensable party” in the committee, citing the reform initiatives of the agency.

“The FDA under director-general Nela Charade Puno has been leading the way in instituting reforms that will benefit the public and also the industry,” the PCPI said. The support was a welcome and surprising development.

Industries in the past had consistently complained of the inefficiency of their respective regulatory agencies. In some instances, they called for the revamp or outright abolition of the agencies. This is understandable. The inefficiency of such agencies have serious negative effects on their business and public service goals.

Puno’s FDA has become an exception. Now, the biggest industry association in the pharmaceutical sector is openly speaking about the positive effects of the reforms in her agency.

Two other associations—the Philippine Pharmaceutical Manufacturers Association and the Chamber of Herbal Industries of the Philippines—have joined the PCPI in giving credit to the FDA.

The FDA leadership is serious not just with internal reforms but with law enforcement as well. Puno has tapped the Philippine National Police to team up with the FDA in an all-out war against unregistered, counterfeit and fake drugs and cosmetics products.

While previous FDA officials had been contented with merely issuing warnings and advisories against such products, Puno went out of her way to make sure the local market was rid of unregistered and counterfeit products through the law enforcement powers of her agency. 

Puno, of course, knows that she is up against major adversaries. She has stepped on big toes and those adversely affected by the reforms will not take things sitting down. She should expect a counter effort, even a black propaganda. She is up against syndicates that make a lot of money duping unsuspecting customers into buying fake or counterfeit drugs and cosmetic products. She should be even more careful of the “syndicates” inside her very own agency.

There are elements there who have perpetuated inefficient systems that give room for corruption. Her reforms are depriving these elements of the money that private entities are forced to shell out just to get the required paperwork done fast.

But some young and idealistic government officials are willing to take risks to improve our lives.

 

 

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Topics: Ray Enano , millennials , healthy lifestyle , food , cosmetics , drugs sector , Food and Drugs Administration , FDA
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