Thursday, February 28, 2008

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.

link to full article

Wednesday, February 27, 2008

FDA plans new post-approval drug safety effort

A step in the right direction...Hopefully the FDA will start to knock these issues off one at a time...hopefully, the follow-through doesn't bog down in bureaucracy...

WASHINGTON (Reuters) - The U.S. Food and Drug Administration is launching a new effort meant to strengthen its oversight of prescription drugs after they win approval, an agency official said on Tuesday.

The plan, called "Safety First," includes creation of a new database of possible side effects from medicines, plus clear schedules for following up on concerns about them.

The effort was first reported by the Wall Street Journal. FDA spokesman Christopher DiFrancesco confirmed the information in the Journal's story.

The action is the FDA's latest move to address charges that the agency has been slow to respond to potential side effects that emerge after a medicine reaches the market.

link to full article

Tuesday, February 26, 2008

Novel genetic technique 'creates' stem cells

Scientists can now transform adult cells to a stem cell-like state without using a cancer inducing gene. Researchers at Harvard University said they can now map the stages of the reprogramming which had thus far been a mystery.

"By defining cellular intermediates of the reprogramming process, our work provides reference points for understanding the molecular mechanisms underlying pluripotent (iPS) cell generation," said Dr. Matthias Stadtfeld, one of researchers on the project.

"For example, one can now take the whole reprogramming process apart into different stages and ask what enzymes or genes are important for the different stages to be initiated and completed."

The team at Harvard Stem Cell Institute and Massachusetts General Hospital have been studying the conversion of mouse adult cells to embryonic-like states by using four genes. The general way to induce iPS cells is to use cancer causing genes to initiate the process and use retroviruses to insert the genes into the target cells - retroviruses which could activate the cancer cells. The use of either oncogenes or retroviruses would make it impossible to use these cells in patients.

link to full article

Friday, February 22, 2008

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.

link to full article

Thursday, February 21, 2008

Amgen calls Roche 'snake-oil salesman'

I can't wait for the the headline of the Street Journal...

"and you're a big doo-doo head!!! there..."

No way, Roche. Amgen rejected a royalty offer from the Swiss drugmaker, which wants to sell an anemia drug that would compete against Amgen's signature blockbusters. Mircera, Roche's version, was approved by the FDA in November, but a jury ruled that the drug would infringe on Amgen's patents. Despite a juicy royalty offer of some 20 percent--twice that paid by Johnson & Johnson for its Procrit med--Amgen is holding fast.

In fact, according to court documents, the California company is scrapping for the fight. After likening Roche to a "snake-oil salesman," Amgen says in court documents, "The only thing more astonishing than Roche's false assertions of its public interests is it chutzpah now in proposing that the Court order a license at a royalty rate of 20 percent."

link to full article

Tuesday, February 19, 2008

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.

link to full article

Monday, February 18, 2008

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 and efficacy," one business ethicist told Pharmalot.

link to full article from fiercepharma

Thursday, February 14, 2008

China Plant Played Role

I am glad to see that the FDA will be inspecting this facility "soon"...

I was discussing this issue with a colleague the other day...we had noted that the vials produced at the plant had tested negative for contaimination and endotoxins...with that infromation, the person I was discussing this with said something alog the lines of "Mark my words, there will be an issue with one or some of the ingredients coming from oversees..."

A Chinese facility that hasn't been inspected by the U.S. Food and Drug Administration made the active ingredient in much of the widely used Baxter International Inc. blood-thinner that is under investigation after reports of hundreds of allergic reactions and four deaths among the drug's users, the agency said yesterday.

The disclosure is likely to add to broad concerns about the safety and quality of products imported from China and elsewhere in the developing world. A tide of tainted goods ranging from pet food to children's toys has prompted recalls and increased scrutiny of Chinese-made wares around the world.

Although it isn't known whether the Chinese plant played a part in the drug's problems, its role as a supplier to Baxter is expected to fuel questions about U.S. regulators' ability to ensure the safety and quality of imported drugs and drug ingredients.

On Monday, Baxter announced that it had temporarily halted production of its version of the generic anticlotting drug heparin because of about 350 bad reactions potentially tied to the drug, including four fatalities, primarily in patients undergoing kidney dialysis and heart surgery.

Yesterday, both Baxter and the FDA said it wasn't clear that the ingredient from the Chinese supplier was tied to the bad reactions. "We honestly don't know" the cause, an FDA spokeswoman said.

link to full article

Wednesday, February 13, 2008

Governor visits Carlsbad to tout biotech industry

biotech as job of my favorite issues...go arnold...

As the state economy sputters, Gov. Arnold Schwarzenegger was in Carlsbad yesterday to shine the spotlight on biotechnology, an industry that is growing.

“We are here today to talk about job creation,” Schwarzenegger said after touring a stem cell lab and manufacturing facilities at Invitrogen, a publicly traded biotechnology company that makes tools for drug-discovery research.
While the state's unemployment rate has climbed to 6.1 percent, biotechnology has continued to sprout and grow, he said. Invitrogen, for example, has grown 5.5 percent in the past year and is expanding its manufacturing capacity by 50,000 square feet and hiring an additional 200 workers, Schwarzenegger said.
In California, 240,000 people are employed in 5,500 life-science companies, which include those that make therapies, medical devices, diagnostics and tools. The industry attracted $3.2 billion in venture-capital investment last year, which was half the nationwide total, the governor pointed out.
And California's $3 billion investment in stem cell research, known as Proposition 71, is helping research institutes attract the best and brightest talent from around the world and fuel potentially lifesaving research, he said.
Schwarzenegger said he wanted to use his appearance at Invitrogen for a round-table discussion with the region's business leaders. Specifically, he wanted to know what state government could do to further support the health and growth of an industry that provides high-skilled and high-wage jobs and is expected to continue growing for many years.
In the San Diego area, the biotech industry returned $8.5 billion to the economy, state Labor Secretary Victoria Bradshaw said.

link to full article

Wednesday, February 06, 2008

FEP Update

Invasion of the Document Snatchers- the Aftermath continues- The Quarterly Review

FDA looks for "boots on the ground" in China

First it was 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.

link to full article

Tuesday, February 05, 2008

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."

link to full article