FDA Drops Hammer on Poor Quality Generic Medicines

FDA Drops Hammer on Poor Quality Generic Medicines

April 16th, 2013 // 1:18 pm @

FDA will impose stricter guidelines to root out generic medicines in the market that are poor in quality, risky, and not effective as their branded counterparts.

In an interview with ABS-CBNnews.com, FDA Acting Director General Dr. Kenneth Y. Hartigan-Go said the “quality of generic medicines has always been questioned by clinicians and the public, and we are determined to show the real quality by imposing strict guidelines for those entering the market.”

Hartigan-Go said the FDA will prepare a list of poor quality generic medicines that are already being sold in the market for the last few years.

“Poor quality generics put patients’ lives at risk, undermine the credibility of the government, public health and medical systems, and waste people’s money and that of PhilHealth money,” he said.

In a separate interview, Philippine Pharmacists’ Association (PPhA) Executive Vice President Dr. Yolanda Robles refused to name these products but said “we’re talking about thousands of products here.”

PPhA is the national organization of Filipino pharmacists that promotes medication safety.

Robles said these products come from a slew of manufacturers, local and foreign. “Sometimes, we don’t know if the papers they are submitting [on the medicine’s quality] are true.”

Based on economist Oscar Pizaro’s discussion paper entitled “Review of the Cheaper Medicines Program of the Philippines” released in June 2012, “brand names in the Philippines have been found to be 5 to 30 times more expensive than similar brand names of similar manufacturers in India and Pakistan.” This is why the country enacted the Cheaper Medicines Law.

“Richer Filipinos tend to use originator brands and ‘branded generics’ sourced from private drugstores and hospitals, while poorer Filipinos rely to a greater extent on lower-priced generics sourced from public facilities and community outlets. The middle class tends to follow richer Filipinos’ use of originator brands and ‘branded generics’ but with greater use of public facilities,” Pizaro said.

But are generic drugs really making Filipinos well?

Hartigan-Go said the agency is already studying the necessity of imposing on pharmaceutical firms the bioequivalence of medicines before their generic drugs can be licensed.

Comparing generics vs innovator medicines

Bioequivalence means that two drugs, for example, should have identical active ingredients and also produce the same effect on a patient.

For example, Robles explained that amoxicillin medicines all have the same ingredient in the capsules. But in innovator products, “the manufacturer has his own formula” that could allow the human to absorb full well the active ingredient of amoxicillin.

She said the clinical trials make the innovative products expensive since it requires recruiting healthy people.

“After a few hours, blood is extracted from the [volunteers]. The tests will show if there is a comparable bioequivalence.”

There are three laboratories accredited by FDA for the clinical trials: UP in Manila, Research Institute for Tropical Medicine in Alabang, and La Salle in Dasmarinas, Cavite.

Robles also said the FDA website is rich in resource materials regarding the current Good Manufacturing Practices (cGMP). These practices ensure quality and safety in the manufacturing, packing, repacking of food and medicines.

Robles clarified, however, that not all cheap generic medicines are bad. This is precisely why the association is pushing for “cheap, but quality” products, she said.

Funding from government

In an FDA report submitted to the two legislative oversight committees two weeks ago, the agency said the Philippine government is to spend P1.93 billion in 2013, P2.01 billion in 2014, and P2.10 billion in 2015 on essential medicines.

This means that FDA will have to strengthen its monitoring system in order not to put to waste the country’s finances.

“The [bioavailability/bioequivalence] studies on generic drugs help ensure consistent production of drug products according to FDA-approved specifications…,” the report read.

Hartigan-Go said the FDA already has plans, which could be optimized via more funding from the government.

Among others, the FDA has already jumpstarted plans of training clinicians – both in the government and private hospitals – to be adept in knowing the bioequivalence of medicines. FDA noted this would mean clinical trials of medicines at any given time.

Hartigan-Go sees another positive outcome on these clinical trials: revenues for hospitals and employment for health care providers. He says clinical trials will be ethical since these will have to comply with FDA standards.

The upgrades will coincide with the Department of Health’s plans, with the help of the FDA, of updating this year the Essential Drug List of the Philippines and Philippine National Formulary. The lists serve as guide for physicians in giving prescriptions.

Google map of drug outlets

FDA has also developed a software to track the drug outlets in the country. Hartigan-Go explained that this uses a Google map where the FDA can upload the location of drug outlets.

“It will help the consumer decide where to buy drugs, taking into consideration the distance from his location and the price of essential drugs,” he said. The project is all about freedom of choice, he noted.

He sees this will help lower the prices of medicines, as affected by the supply and demand. “This is a form of a market-driven and demand-driven scheme for lowering drug prices since the chains of drugstores will have incentives to lower their retail prices to compete for market shares.”

He said, however, that the project will be successful if the FDA is allowed to purchase gadgets or tablets for field inspectors who will be tasked to locate and track the drug outlets. He said the gadgets are needed for transmitting reports to the main office and cut down time for licensing procedures.

He said these will be used “to transmit reports to FDA for printing and basis for preparing the issuing certificates or notice of deficiencies to establishments.”

Around P2.2 trillion of the total household expenditures in 2012 were spent on products directly within the FDA’s jurisdiction. This jumps to P3.27 trillion if industries affected by the production of such products are included.

Based on 2011 figures, the Philippines spent $2.91 billion in pharmaceutical and healthcare products and $13.17 billion in food and drinks.

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