Budget Juggling...

Maybe everybody who lose's their job at the NIH...Slowdown In National Institutes of Health (NIH) Funding Creates 'Quiet Crisis'

Can get a job with the FDA...Agency To Add More Than 1,300 Scientists

Operation Jupiter rains on fake antimalarials

anti-counterfeiting operations...sounds exciting...

A multinational, multidisciplinary initiative involving scientists, public health workers, police and government officials could provide a cogent model for rooting out and stamping out counterfeiting of essential and lifesaving drugs.

But replicating 'Operation Jupiter', which employed a battery of forensic tests ranging from mass spectrometry to palynology (pollen analysis) to track down a source of fake artesunate in southern China, would require technical capacity and resources as well as collaborative efforts that at present are sorely lacking in the countries most affected by counterfeiting.

In the developed countries where fake pharmaceuticals are still at a relatively low ebb, counterfeiting can infiltrate a wide range of drugs, but in particular lifestyle products such as the erectile dysfunction treatments Viagra (sildenafil citrate, Pfizer) and Cialis (tadalafil, Eli Lilly).

The focus of the operation co-ordinated by the World Heath Organization's (WHO) Western Pacific Regional Office, the International Criminal Police Organisation (INTERPOL) and the Wellcome Trust-University of Oxford South-east Asian Tropical Medicine Research Programme, in close co-operation with the Chinese authorities, was a generic medicine for a tropical disease that threatens some 40 per cent of the world's population and still claims over a million lives a year.

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Baxter unaware plant not inspected

Baxter International Inc. does not monitor its supply chain to the extent that it would know that a supplier in China was never inspected before it began shipment of the blood-thinning drug heparin, which is linked to more than 300 illnesses in the U.S., the company's chief executive said Wednesday.

Baxter contracted with a Wisconsin supplier, Scientific Protein Laboratories, and not with that company's Chinese affiliate, Baxter CEO Robert Parkinson said Wednesday in his first interview since the heparin problems surfaced.

"It's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier," Parkinson said.

Deerfield-based Baxter's troubles with heparin highlight the concerns many U.S. companies and consumers have about their vulnerability to errors by suppliers from China and other less-developed countries. Problems with tainted toys, toothpaste, tires and pet food from China in the last year preceded Baxter's issues with heparin, made from an active ingredient imported from China.

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FDA Says It Approved The Wrong Drug Plant

and things go from bad to worse...

sometimes the last thing you want to do is find out what is really going on...'cause it might be scary to contemplate...

Heparin Probe Sends Inspectors to China

The Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected by the Food and Drug Administration because the agency confused its name with another just like it, agency officials said yesterday.

The FDA said that a team of inspectors is headed now to China to inspect the plant as part of an effort to determine what may have caused a sudden spike in serious problems with the drug, which has been on the market since the 1930s.

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Congressman: FDA chief should resign

Now that Congress has solved the "steriods in baseball issue", they can move on to bigger and better things...

politicizing the FDA!!!...

The heparin pile-on has begun--but this time, the FDA is at the bottom, not the drugmaker. As Baxter analyzes product samples for impurities that might have caused 350 adverse reactions, including four deaths, Congress and other critics are pointing fingers at the watchdog agency. And the FDA itself admits that yes, it violated its own procedures in approving the drug for sale without inspecting the Chinese plant where its active ingredient was made. One key Congressional critic is even asking FDA chief Andrew von Eschenbach to step down.

Baxter, of course, isn't getting off scot free. Its internal investigation is squarely under the media spotlight. So far, the company has found some differences between problem heparin vials and controls, and some of the differing samples did come from China. But so far, said a company spokeswoman, "[I]t's unclear what the impact of these differences is."

Baxter also ID'd the supplier in question, which it had refused to do before. The API maker is Scientific Protein Laboratories, a Wisconsin company that makes bulk heparin at a Chinese factory and at another at HQ. SPL says both plants adhere to the same industry and FDA safeguards. The agency is prepping an inspection team to check out the Chinese plant, and Baxter plans to send its own investigators. But plant personnel know inspectors are coming. "We'll fully cooperate," said a quality-control manager at the Chinese plant.

The big question posed by lawmakers and consumer advocates alike: With most bulk drug ingredients made overseas now--and only 7 percent of foreign plants inspected a year--what else is falling though the cracks? Some even want lawmakers to bar Chinese-made pharma ingredients. "China is fundamentally incapable of safeguarding...safety and efficacy," one business ethicist told Pharmalot.

link to full article from fiercepharma

FDA looks for "boots on the ground" in China

First it was India...now China...

WASHINGTON (Reuters) - The United States is hoping to bolster the safety of food and other products imported from China by opening a new Food and Drug Administration office in the Asian nation.

"We will be able to continue to expand our own ability to leverage, beyond simply sending inspectors over, but to have people in place," FDA Commissioner Andrew von Eschenbach said during the Reuters Regulatory Summit here.

"We're boots on the ground," he said.

FDA officials see the office, which must be approved by the Chinese government and funded by Congress, as a model for outposts elsewhere, which in an era of globalized trade would shift much of the burden for safe imports to producer countries instead of relying on inspections at home.
Von Eschenbach said FDA officials in China, rather than regularly patrolling factories, would seek to create more stringent safety standards among producers and would look to strengthen regulation by Chinese government.

Basing officials in China would also allow the FDA to move quickly when problems do arise, rather than having to secure visas or make long trips before setting off to inspect problem facilities.

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US FDA budget seeks biotech generics, user fees

People are starting to talk about the impact of the political system on the FDA...

Not good to see this function impacted by politics...


WASHINGTON, Feb 4 (Reuters) - New fees for the Food and Drug Administration to speed review of generic pharmaceuticals and new authority to approve copycat versions of some biotech drugs were proposed in President George W. Bush's budget on Monday.
The White House requested an FDA budget of $2.4 billion for the 2009 fiscal year starting in October, a 5.7 percent increase over last year's budget.

The proposal comes as the FDA faces heightened criticism for inadequate staffing, lax oversight of drug and food safety and out-of-date technology. Last week, lawmakers met to discuss a report by an independent board that concluded lives are at risk because the agency is so underfunded and behind in cutting edge science.

"It's pretty disappointing, especially in light of the overall unanimity of concern over food safety and drug safety," said Bill Hubbard, an advisor to the Alliance for a Stronger FDA, and former associate FDA commissioner from the early 1990s through 2005. The Alliance is made up of industry, and consumers and patient groups.

Hubbard said that because FDA's costs are more aligned with medical costs, which are rising faster than overall consumer inflation, "it's barely half of what FDA needs just to keep pace with inflation."


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FDA considering establishing Indian presence

Can this even be considered out-sourcing???...

The US Food and Drug Administration (FDA) is considering establishing a presence in India, amidst the country's growing ties with the US pharma industry.

FDA commissioner Andrew Von Eschenbach and US Health and Human Service (HHS) secretary Michael Leavitt have been visiting India to assess the manufacturing practices at some of the facilities there. The visit was largely initiated in response to mounting apprehension over the quality of both food and drugs and related ingredients being imported into the US. The current import protection system was described by Leavitt as "inadequate."

Some Indian media reports have also claimed that the visit was made because the FDA is planning on setting up an office in the country. On the flip side, other media reports have said that the FDA is not planning such a move. Outsourcing-Pharma.com confirmed with an FDA spokesperson that at this point the agency is just offering advice and guidance to the Indian authorities who are looking at setting up a regulatory body that is comparable to that of the FDA.

During his trip to India last week, Leavitt stated: "Basically, we would be glad to try to provide technical assistance to the Indian government as it further develops its new regulatory agency/ies."

He also said that "we are considering trying to establish an FDA presence/office in India," although no decision has been made as yet, the spokesperson advised.

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Biotech industry facing closer scrutiny

Florida weighs in...

and new Jersey gets a mantion...'cause we're talking about regulations...

Biotechnology as an industry is growing, but with its higher profile has come greater scrutiny from government, which also is one of its biggest customers.

Industry lobbyists meeting here Wednesday on the second and final day of the 10th annual BioFlorida conference outlined the increased regulatory activity biotech companies are running into from federal and state governments.

Forty-six states, including Florida, enacted "anti-industry" legislation last year, said Christopher Badgley, vice president of the Pharmaceutical Research and Manufacturers of America.

The industry faces drug-price controls, limits on patient access to new treatments, drug-safety concerns, mounting clinical-trial disclosure rules and changes to intellectual-property laws, he said.

"Public policy is often emotion-based. It has less to do with what's the best policy and more with what gets (officials) elected," he said.

According to the lobbyists, New Jersey's attorney general has formed a task force to investigate compensation drug and biotech companies pay to some doctors who test new treatments. In Washington state, the legislature established a board to review a new medical technology or treatment and to recommend whether it should be supported by state employee health coverage.

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