FDA Warns Public of Extortion Scam by FDA Impersonators

and you thought all you had to worry about was e-mails from dethroned Nigerian princes...

FDA Warns Public of Extortion Scam by FDA Impersonators

The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.

Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic. No medications are ever delivered. A subsequent call is received from a fraudulent "FDA special agent" informing the consumer that a fine of several thousand dollars is required to be sent to an address in the Dominican Republic to prevent incarceration or other legal action.

"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business."

Consumers should note that the fraudulent calls appear to be from telephone numbers located within the United States, but are in fact from either ported voice-over-the-Internet-protocol numbers (calls made directly from a computer and moved or "ported" to other computers to avoid detection) or cellular phones. Reports to FDA describe the callers as having Hispanic accents.

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Only 59% of Pharma Companies...

Own Dedicated Compliance Departments, According to Research by Cutting Edge Information

Can this possibily be correct???...

A stand-alone Quality function is a direct requirement of federal law governing GMP activities...21CFR etc etc etc

I'll have to download the report and read it...that's funny...it's so questionable, I'll take the time to read it...

A new study by business intelligence firm Cutting Edge Information finds that only 59% of pharmaceutical companies currently own dedicated departments for compliance. The study, "Monitoring and Ensuring Pharmaceutical Compliance," highlights the growing need for creating a dedicated compliance department.

With only 59% of pharma maintaining a dedicated department for compliance, there are still a healthy percentage of companies who remain vulnerable to unforeseen regulatory changes. Building a strong compliance management team will give the staff the necessary power to effectively manage their internal clients' changing needs.

Maintaining a dedicated compliance department also signals to outside agencies that the company takes regulation seriously. Giving an outward appearance of a company willing to police itself goes a long way in the court of public opinion. The damage done by a compliance misstep can take a long time to recover from -- both legally and in the eyes of company stakeholders.

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link to report download

Counterfeiters can get life in jail under new US Act

US President George W Bush has signed a bill under which counterfeiters can be sentenced to life imprisonment if their crime causes the death of an individual.


The passing of the Prioritizing Resources and Organization for Intellectual Property Act of 2007 (PRO IP) strengthens the US court’s power to punish those convicted of counterfeiting; a measure big pharma has been calling for.

By increasing its maximum penalty the US has brought its punishment more closely into line with China, which sentenced a man to life in prison for causing 14 deaths by using a fake ingredient in human immunoglobulin.

The sentence for inflicting serious bodily harm as a result of counterfeit products has also been increased and can now result in up to 20 years in jail. Both sentences can also carry a fine.

In addition to increasing the punishments for trafficking counterfeit goods the new legislation also ramps up US preventative powers.

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US proposes country-of-origin labelling

A good start...we have to start protecting ourselves...

A bill has been introduced to the US Senate that would require the country-of-origin of APIs and excipients to be labeled on finished dosage forms.


This proposal covers both active pharmaceutical ingredients (APIs) and excipients present in prescription or over-the-counter (OTC) products.

Including excipients under the bill differentiates it from the proposal in the draft of the US Food and Drug Administration (FDA) Globalization Act, which was released in April.

Under the proposal the country-of-origin of each active and inactive ingredient would be listed in descending order based upon the quantity in the finished dose.

It appears that it will not be necessary to include the country of origin of all raw materials and intermediates, or the nation in which every step in the synthesis process occurs.

This would provide a more comprehensive view of the origins of an API or excipient but is not mentioned in the bill, probably due to the complexity of implementing such a measure.

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FDA faulted for produce oversight

Who plans a "foodborne illness outbreak"???...

WASHINGTON (Reuters) - Preparations for a biological attack and repeated outbreaks of food poisoning have interfered with efforts by the U.S. Food and Drug Administration to improve the safety of fresh produce, according to a report released on Friday.

The agency is also unclear on what it plans to do to shape up, the Government Accountability Office said.

"While FDA has considered fresh produce safety a priority for many years, resource constraints and other work -- including counterterrorism efforts and unplanned events such as foodborne illness outbreaks -- have caused FDA to delay key produce safety activities," the GAO report reads.

"FDA has no formal program devoted exclusively to fresh produce and has not consistently and reliably tracked its fresh produce spending."

It said the FDA spent at least $20 million or about 3 percent of its food safety dollars on fresh produce in 2007.

The fresh produce industry has indicated it would welcome stronger regulation, especially after outbreaks of Salmonella carried by peppers from Mexico and that sickened 1,400 people from April to August of this year and an E. coli epidemic in 2006, traced to California spinach, that killed three.

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New GMP Regs

The FDA has responded to industry comments with some new rules...

FDA publishes final rule on cGMP amendments

FDA to List Drugs Being Investigated

Talk about "Direct to Consumer" marketing...this sound like "do it yourself" drug safety review...

The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients.

The FDA will name the drug and the nature of the "adverse events" but will not describe their seriousness or the number of complaints received, officials said yesterday. Being on the list does not mean the drug is unsafe, only that the FDA is looking into that possibility.

FDA officials said they realize that the new policy, required by changes to federal law enacted last year, may unintentionally alarm some patients.

The agency's Adverse Event Reporting System (AERS) last year received 482,154 unsolicited reports of potential reactions to drugs. The vast majority were false alarms, with the reported problem having nothing to do with the medication a patient was taking.

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FDA seizes drugs worth $74,000

How come we can't get this level of enforcement on real drugs??...

The US Food and Drug Administration (FDA) has ordered the seizure of $74,000 worth of Xiadafil VIP tablets after SEI Pharmaceuticals refused to withdraw them from the market.

A formal request for the recall of the erectile dysfunction dietary supplement was issued by the FDA after it discovered batches contained an undeclared active pharmaceutical ingredient (API).

SEI refused to recall the products leading to the FDA enlisting US Marshals to seize the batches to prevent more illegal Xiadafil from being sold.

Margaret Glavin, associate commissioner of the FDA’s Office of Regulatory Affairs, said: “Today’s seizure action shows that the FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers.

“The FDA will not tolerate a company’s failure to take voluntary action to protect the public health after being given the opportunity by the FDA to do so.”

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Heparin taint tied to deaths

FDA: 3 fatalities linked to material in Baxter product

The U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients infused with the blood thinner heparin to a foreign substance found in specific lots of the drug made by Deerfield-based Baxter International Inc.

In an interview Tuesday with the Tribune, the FDA said it completed its review of 93 death reports related to heparin that the agency received from Jan. 1 to March 31, a period when there was a dramatic spike in potentially deadly allergic reactions from patients who had been injected with heparin. The popular blood thinner is used widely in large dosages, often before patients have dialysis or heart surgery.

Of 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for an animallike substance known as oversulfated chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those 7 patients received heparin contaminated with the substance.

"We have what looks like a cause and effect in some patients," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an interview, referring to the three deaths linked to contaminated heparin. "We know that they got contaminated heparin, and they died subsequently. This is one of the final links in the chain."

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Senate Appropriations Committee Approves $2 Billion for FDA

Now they're gonna regulate the #@&?#!!! out of us...

The Senate Appropriations Committee unanimously passed an appropriations markup measure Thursday, providing the FDA with a $2.04 billion fiscal 2009 budget.

This amount is $324.6 million more than the agency initially received for fiscal 2008. The measure will have no number until it is introduced in the full Senate.


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FDA Moves Forward With Exempting Phase I Drugs From GMPs

So much for those bothersome regulations...

More than two years after withdrawing a final rule that would have exempted investigational drugs in Phase I testing from certain good manufacturing practice (GMP) regulations, the FDA is issuing a final rule to do just that.

The new rule, which amends the GMP regulation with the exact same language as the withdrawn rule, was published in Tuesday’s Federal Register. Slated to take effect Sept. 15, it will apply to small-molecule drugs and biologics, including vaccines and gene therapy products.

“FDA’s position is that the United States’ [GMP] regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture,” the agency says.

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Drugmakers: Prepare for a Smackdown

The FDA plans to lay heavier regulations on Big Pharma.

For years the Food and Drug Administration has failed to adequately monitor the pharmaceutical industry. That conclusion by a special committee at the Institute of Medicine in a September 2006 report titled “The Future of Drug Safety” helped prompt a sweeping reform bill that became law last September. The Food and Drug Administration Amendments Act of 2007 gives the FDA the dollars and legal clout it needs to make a number of important fixes. Its key provisions and other new initiatives include these:

• The FDA will hire 1,300 new employees, with at least 400 dedicated to drug review.

• The agency has earmarked money for the development of a network of organizations to monitor the safety of FDA-approved drugs. Assembled and led by the FDA, the network participants—which include health-care insurers and providers—will have the ability to search millions of their own database records at the agency’s request. This surveillance system is built to identify problems, such as side effects of pharmaceuticals and medical therapies, as they emerge.

• All clinical trials of every FDA-approved drug must be registered on an NIH Web site, with results of those trials also posted.

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FDA might finally get its $275 mil

Job Fair at the FDA!!!...and you thought the life science job market was slow...

The FDA funding question has come full circle. First, the government's watchdog, the General Accounting Office, said FDA needed more money to do its job effectively. Then Congress asked FDA officials--repeatedly--to name a figure. A few months of that prodding finally yielded a number from Commissioner Andy von Eschenbach: $275 million.

Now, the Bush administration has seconded that figure, asking Congress to give FDA the money. HHS Secretary Michael Leavitt urged "Congress to act quickly to enhance the safety of food and medical products." With the added funds, FDA would open offices in China, India and Central America and hire another 490 people on top of the new employees it's already adding, bringing the total workforce expansion to 1,500, or 10 percent.

Apparently the big salmonella outbreak, linked to raw tomatoes, was the straw that broke the government's back. Coming on the heels of contaminated dog food, toothpaste, heparin, and more, the tainted tomatoes became one headline too many.

link to fiercepharm article

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FDA: 11 Deaths In Medical Devices Tied To Heparin

Unfortunately, we are now moving on to medical devices...

WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration has received reports of 11 deaths and other adverse events associated with medical devices that contain heparin, a widely used blood thinner that has sparked Congressional inquiries about the agency's oversight of drug manufacturing.

The FDA, in documents posted on its Web site Thursday, said it can't determine at this time whether the devices cited in the reports contain contaminated heparin.

Most of deaths were reported by families. As a result, FDA spokeswoman Karen Riley said, the agency in many cases can't identify the manufacturer or from which lots the heparin came. The FDA is working to contact the families to try to find more information.

Riley said the FDA was able to trace back two of the death reports to conclude that the heparin wasn't contaminated in those cases.

Contaminated heparin from China had previously been linked to 81 deaths in the U.S. and hundreds of allergic reactions. Baxter International Inc. (BAX) is the largest supplier of heparin.

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and Here We Go...

The Chinese start the "active evasion" portion of this tragedy...asking if people who were taking a drug used in dialysis had kidney disease...

China accuses US of shoddy probe into tainted heparin

BEIJING - China's drug safety agency accused the United States on Tuesday of blocking Beijing's inquiry into a blood thinner linked to 81 deaths by refusing to provide details on victims and specifics about production.

Two Chinese experts who attended a conference on the drug, heparin, in suburban Washington, D.C., last month said the U.S. determined a contaminant was likely to blame without considering other possible factors.

"We need to resolve this in a scientific matter, not just by blaming a contaminant," said Jin Shaohong, a member of the drug evaluation committee of China's Food and Drug Administration. "I think it is too early to say that."

Besides the deaths, hundreds of patients have suffered severe allergic reactions to large doses of heparin, which is used in dialysis and other treatments.

The U.S. Food and Drug Administration said it suspects the problems stem from a contaminant the agency discovered in supplies of raw heparin coming from China — a compound derived from animal cartilage that so closely mimics heparin that routine tests can't detect it.

The Chinese experts said U.S. officials and Baxter International refused to give them information to probe the possibility that drug interactions, patients' medical histories or safety issues after the raw material left China may have played a role.

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Report: Risky tests of blood substitutes allowed

The products in question here are very different from each other...

Pooling data would make almost no sense...safety trials would be a good idea, which the FDA strongly recommended, and they enforced their own recommendation...check the timing of Biopure's stock dropping several years ago as compared with the FDA response letter...

other details gets washed over in this article as well...

FDA permitted human testing despite warning signs, report charges

CHICAGO - Experimental blood substitutes raised the risk of heart attack and death, yet U.S. regulators allowed human testing to continue despite warning signs, says a scathing new report.

The U.S. Food and Drug Administration fell short, the report contends, even as red flags popped up during studies by five biotech companies. Rules barred the agency from releasing company trade secrets, and that kept some information hidden and may have led to unnecessary heart attacks and deaths, wrote the authors, who are government scientists and consumer advocates.

“There shouldn’t be secret science,” said the lead author of the report, Dr. Charles Natanson, of the National Institutes of Health Clinical Center. Safety data need “to be made public expeditiously so science can build on the mistakes” of previous research, he said.

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FDA suspects heparin contamination due to fraud

The US Food and Drug Administration (FDA) believes that the contamination of Baxter's blood thinner heparin, which has been linked to 62 deaths in the US, may have been due to the deliberate replacement of some ingredients with cheaper alternatives.

Analysis by the agency recently established that the drug lots in question contained oversulfated chondroitin sulphate, which is a less-expensive, animal cartilage-derived alternative to raw heparin that is not approved for use in medicine. Oversulfated chondroitin sulphate has been implicated in causing the hypersensitivity reactions associated with contaminated heparin.

FDA Commissioner Andrew von Eschenbach told the US Senate on Tuesday that the agency suspected the ingredient switch had been made "by virtue of economic fraud," but added that it would leave further investigation of the matter to Chinese State Food and Drug Administration officials.

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FDA Product Safety Alert for Heparin

the Heparin saga continues...

Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution

Has Biotech gone the way of Big Pharma?

Think Big Pharma has problems with their pipeline?...

Check out this report recently published by Ron Rader of the Biotechnology Information Institute

The report focuses on recent approval trends for biotech products with current approval data thru 2007...and, quite frankly, the news is not good...

Ron is also publishing reports detailing industry information for the biotech market sector...

Contaminant found in heparin

WASHINGTON - U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug.

The lots of heparin, whose key ingredient was imported from China, were recalled Feb. 28, and Food and Drug Administration officials said Wednesday that no new deaths have been reported since that time.

Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said the contaminant is oversulfated condroitin sulfate, a chemical that does not occur naturally.

Condroitin sulfate is a natural compound that occurs widely and is used as a dietary supplement but the oversulfated version has not been widely studied.

"We cannot rule in or out whether this was accidentally or deliberately introduced into the product," Woodcock said, "We are investigating how it got in."

The FDA has also initiated testing of imported heparin entering this country and Woodcock said the agency feels "doctors and patients now can be confident that the product on the market has been tested and is safe."

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