AM2PAT is now the subject of a criminal investigation. Federal investigators say the company was so focused on making profits that it did not conduct necessary safety tests and instead covered up the matter by falsifying reports to make it appear those tests had been conducted.

Earlier this week, workers at the plant pleaded guilty for their roles in the scandal and were sentenced to four years in prison. The company’s president, Dushyant Patel, faces numerous charges but has apparently fled to his native country India. If convicted, he faces up to 95 years in prison.

According to reports, the FDA received complaints that there were “orange specks,” or “yellow sediment” floating in the unopened syringes, or that the medicine inside appeared “muddy brown.” Despite the reports, which are recorded as early as November 2005, the FDA didn’t follow up on the complaints until 22 months later.

Food and drug manufacturing plants should be inspected by the FDA every two years, but many plants, such as AM2PAT have received site visits about every five years, according to a report from the Government Accountability Office. The report also shows that between 2002 and 2007, FDA inspectors visited only about 25 percent of the 5,616 registered plants each year.

SOURCE: Heparin Recall › FDA knew of tainted syringes two years before inspecting plant

Such is the case with the blood thinner heparin, which last year was the focus of much scrutiny when 80 Americans died and hundreds more were sickened after receiving doses of heparin manufactured in China. An investigation found that batches of heparin manufactured in Baxter International’s China plant had been contaminated with oversulfated chondroitin sulfate (OSCS). OSCS mimics the appearance of heparin but cause adverse reactions and even death.

Years ago most drugs were manufactured in the U.S., but over the years those operations have moved overseas – in particular, to Asia – where labor, construction, regulatory and environmental costs are lower. The FDA also inspects domestic plants far more often than foreign ones, which also adds to pharmaceutical companies’ production costs.

Following the heparin contamination last year, the FDA admitted that it was not sufficiently staffed to inspect all foreign offices. Thus, the agency has since begun to set up offices in foreign countries. To date, offices have been placed in China and India. The FDA also launched a voluntary two-year “Secure Supply Chain” pilot project to help promote the safety of drugs and active drug ingredients made outside the U.S.

SOURCE: Heparin Recall › Lawmakers call for rule requiring drugs be made in U.S.

Last year the FDA announced it would place more than 60 food and drug regulators worldwide in an effort to keep unsafe drugs out of the country. Late last year the first offices opened in China, a country whose products have made headlines over the past several months for harming hundreds of thousands of people around the globe.

Aside from lead paint on toys, faulty cribs, tainted pet food and contaminated milk, China was also the site where investigators found a drug manufacturing company had contaminated batches of the blood thinner heparin with oversulfated chondroitin sulfate (OSCS). OSCS mimics the appearance of heparin but can cause adverse reactions and even death.

Before the contaminate was detected, the OSCS-laced heparin was imported into the United States, where it was administered to patients. The tainted heparin killed more than 80 people and sickened hundreds more.

The FDA reports that India is the fourth largest exporter of drugs and biologics into the U.S., according to Med Page Today.

The FDA also announced last week that it will launch a voluntary two-year “Secure Supply Chain” pilot project to help promote the safety of drugs and active drug ingredients made outside the U.S. The program is designed to assist the FDA in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements.

SOURCE: Heparin Recall › FDA opens offices in India to help oversee drug importation

If so, Dashle will inherit a department that oversees the FDA, an agency that is rife with issues. The agency has been the subject of criticism over its handling of the tainted heparin scandal earlier this year in which more than 80 Americans were killed and hundreds more sickened after receiving injections of heparin from China.

The FDA, struggling with low staff levels, is gradually hiring more employees. It recently began placing food and drug inspectors and opening foreign offices – the first of which was in Beijing, China – in an attempt to oversee quality control of food and drugs imported into the U.S. However, hiring enough staffers to fully inspect those foreign manufacturing plants could take years.

“The people who have been doing the hiring say it will take three years to get those folks up and running and fully trained to carry out any work,” said Marcia Crosse, GAO’s director of health care, in the Federal Times story. “They’ve had to shift away from the traditional model of having other countries oversee their own pharmaceuticals. Where we may have trusted Germany to oversee its companies, the same can’t be said for China and India.”

The National Treasury Employees Union president says she is hopeful that the Obama administration will make hiring more inspectors, scientists and chemists for the agency a priority.

SOURCE: Heparin Recall › Daschle likely to inherit agency rife with issues

First, researchers noted that the evaluations were short term and that many of the studies were supported by the generic drug companies, who have a vested interest in the positive outcome of the results.

Furthermore, the story points out that generics are more likely to be made in factories in other countries where labor and overhead are far less expensive, such as India and China. In fact, China is producing more and more generic drugs and, according to the story, is expected to offer even lower prices in the future.

This should raise concerns with the general public, given the tainted heparin scandal earlier this year that killed more than 80 Americans and sickened hundreds more. That tainted heparin was traced to manufacturing plants in China and resulted in a major recall of the blood thinner.

The FDA is hoping to give more guidance on U.S. quality control standards on imported food and drugs by opening offices and placing regulators in foreign countries. The first office opened in Beijing last month. However, congressional investigators say that inspecting the more than 3,000 drug plants in other countries could take more than a decade.

SOURCE: Heparin Recall › Generics may be bio-equivalent of brands, but are they as safe?

The move is part of the agency’s effort to place more than 60 food and drug regulators worldwide over the next year. The offices replace the FDA’s previous practice of sending staffers on individual assignments to inspect foreign facilities.

The agency’s Beijing office, which opens Wednesday, will be the first. Thirteen employees will be assigned to work in the China offices.

The AP quoted a statement from the office of U.S. Health and Human Services Secretary Mike Leavitt: “Establishing a permanent FDA presence in China will greatly enhance the speed and effectiveness of our regulatory cooperation and our efforts to protect consumers in both countries.”

The FDA is placing offices worldwide with particular attention to India, Latin America and the Middle East. However, placing offices in China became a priority as a result of numerous reports of contaminated food and drug products manufactured in China. Among the products made in China and recalled by the FDA were batches of the blood thinner heparin, which were found to have been contaminated with over-sulfated chondroitin sulfate (OACA). More than 80 Americans and hundreds more fell ill after receiving the contaminated heparin.

SOURCE: Heparin Recall › FDA opens first foreign office in Beijing this week

“We are sending a very clear message to producers: if you want to have access to our market you need to make products that meet our standards of quality,” Health and Human Services Secretary Michael Leavitt was quoted in the story. Leavitt oversees the FDA and other federal health agencies.

While particular attention will be paid to India, Latin America and the Middle East, the FDA will make China a priority, establishing its first office in Beijing by the end of the year. The Beijing office will employ eight U.S. staffers. Additional outposts are planned for Shanghai and Guangzhou.

Products made in China have caused much heartache lately. Last spring, the FDA
recalled batches of heparin after some lots were found to have been contaminated while produced in Baxter International’s Chinese factory. The tainted heparin killed more than 80 people and sickened hundreds more.

Similarly, dozens more products made in China have been recalled over the past several months for harming people, including tainted baby formula, toys made with lead-based paint, and contaminated pet food.

Details on how the FDA will carry out the plan are unclear, as FDA officials admit that the hiring of several dozen more staffers, as the plan lays out, would not provide enough personnel to visit the thousands of plants around the world.

SOURCE: Heparin Recall › FDA to set up offices worldwide