Healthy Skepticism Library item: 3825

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Diani H.
Embattled BPOM chief says agency doing its job to monitor drugs
The Jakarta Post 2006 Feb 18
http://www.thejakartapost.com/yesterdaydetail.asp?fileid=20060214.B02

Notes:

Ralph Faggotter’s Comments:

I wonder if Indonesia’s Food and Drug Monitoring Agency (BPOM) has the same revolving door employment arrangement with the pharmaceutical industry, for its employees, which the FDA does?

Full text:

Embattled BPOM chief says agency doing its job to monitor drugs

National News – February 14, 2006

Although known for his Javanese politeness and fine manners, Food and Drug Monitoring Agency (BPOM) chief Sampurno was clearly irritated when asked about criticism his organization has failed to properly monitor and regulate the pharmaceutical industry.

“It’s all talk with no proof,” he said.

After the flak BPOM received last month, when carcinogenic formaldehyde was found being used to preserve tofu and other food, his sensitivity is understandable.

Many also fault the agency for the haphazard drug situation in the country, which is not limited to high pricing and overdosage.

Prof. Iwan Darmansjah of the University of Indonesia’s medical school said the local market was awash with useless drugs which drained the funds of unwitting consumers.

“False drug claims and wrong doses are blatantly condoned and fill the pages of the formal drug information (guide) called MIMS Indonesia,” said the pharmacologist and doctor.

For those who like to self medicate, cheap drugs are readily available on the black market, such as Pasar Pramuka in East Jakarta and Pasar Senen in Central Jakarta. There are dozens of drug stores, selling products of questionable quality, safety and efficacy over the counter.

Cases of fake drugs are rampant, as well as substandard drugs, which contain less active compounds than defined on their labeling.

“In Indonesia, governance of drugs has never been well organized. The BPOM never had the manpower and the organization to protect the public from the presence of bad drugs on the market. The BPOM has been closer to and more protective of the industry than the public,” Iwan said.

Marius Widjajarta of the Indonesian Health Consumer Empowerment Foundation said the situation worsened after the BPOM was removed from the auspices of the Health Ministry in 2001.

The agency was separated to become a stronger, independent body (the only other country to do this is China) after butting heads with the ministry on authority.

“The agency liked to usurp the ministry’s authority, from drug registration to issuing permits to build pharmaceutical factories. From 2002 through 2004, the agency approved 240 import licenses, which they had no right to do. Monitoring drugs is already a gargantuan task, so why trespass on other’s authority?” he said, adding the agency should be moved back to the health ministry.

Sampurno defended his ministry against all the allegations, saying the BPOM did its job. He noted it was selected the fourth best agency in the world according to the 2005 audit of WHO.

He denied drugs were too pricey here, saying there was a wide selection of products available with a varied price range but of similar quality.

“When it comes to generic drugs, it’s very competitive. The key is to exercise patients’ rights, so they don’t just bow to doctors’ prescription prices,” Sampurno said.

Effectiveness of drugs, he added, was a subjective matter.

He also termed “an emotional recommendation” the calls to return the BPOM to the Health Ministry.

“Come on, compare the performance of the agency (now) to when it was still part of the ministry. You can see that we perform better as an independent body.” — JP/Hera Diani