More Counterfeit Bevacizumab Raises Legal Questions for Oncologists

The Food and Drug Administration has identified another batch of counterfeit bevacizumab in the United States, bringing with it concerns for physicians about their legal liability in the complex world of foreign-supplied drugs.

Agency lab tests confirmed that vials of Roche’s Altuzan 400 mg/16mL – a brand of bevacizumab approved in Turkey – contain no active ingredient, the FDA announced early in April. The only bevacizumab brand approved in the United States is Avastin, a product distributed by Roche-owned Genentech.

Subsequently, the agency sent letters to specific physicians in 13 states, who are believed to have purchased medications from foreign or unlicensed suppliers that sold illegal prescription medications. These medical practices "are putting patients at risk of exposure to medications that may be counterfeit, contaminated, improperly stored and transported, ineffective, and dangerous," the agency warned in the letters.

"Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States. ... In virtually all cases, purchasing unapproved prescription drugs from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal," it advised the recipients.

Physicians Could Face Malpractice Suits

This language raises questions about physician liability when drugs are obtained from foreign distributors that have not been approved by the FDA. Not only do concerns about safety come into play, but intellectual property rights do as well, according to Dr. Maxwell Gregg Bloche, who is a physician, a professor of law, and codirector of the Georgetown–Johns Hopkins Joint Program in Law and Public Health.

Dr. Bloche emphasized a distinction between "the vast majority of prescriptions, which are not being supplied in the office" and those such as bevacizumab that are delivered in the context of a medical practice. In the former, the physician – acting as an enforcer of intellectual property law – could be acting against the interests of patients who might suffer terrible health consequences as a result of not being able to afford the drug. "However, when it comes to known counterfeit drugs that could be seriously dangerous, the physician’s role is to safeguard the patient," he said in an interview.

Adding complexity to the situation is an array of FDA-approved foreign suppliers, those foreign companies that knowingly supply dangerous or ineffective drugs, and a third category of suppliers that fall in between.

Outside the United States, there are reputable, high-quality pharmaceutical companies that offer generic drugs at much lower cost, noted Dr. Bloche. However, these companies often do not recognize U.S. patent laws. Only the name-brand drugs are legally available in the United States, until the FDA approves generic versions of those drugs.

"The physician is responsible for making medically sound judgments about risk," he said. If a patient mentions getting a prescribed drug from a foreign source, the physician can indicate that the source produces high-quality, generic versions. The patient may be breaking U.S. laws by doing so; the physician merely offered an opinion.

State malpractice laws come into play once the FDA has identified foreign suppliers that are selling counterfeit drugs – as in this round of counterfeit bevacizumab – and has warned physicians and the public, according to Dr. Bloche. Any physician who is still prescribing and/or using the drug for patients, or who tells the patient that the drug is safe, is then potentially liable.

"I think the medical malpractice law is the one that most physicians are going to be afraid of, which is a state tort law issue, said Dr. Bloche.

In recent months, one oncologist has been prosecuted on charges of distributing and receiving "misbranded and adulterated" prescription drugs in a case brought by the United States Attorney’s Office for the Eastern District of Missouri. Dr. Abid S. Nisar pleaded guilty to one count of "misbranding drugs," according to a government statement. The legal action was part of a larger case involving Neupogen, Herceptin, and Rituxan, but not Avastin, and a distributor known as Ban Dune Marketing Inc. (BDMI).

Buy From a Reputable Distributor

For practicing oncologist Dr. Patrick W. Cobb, "the main way that you know that you’re getting the right thing is to buy it from a reputable distributor. ... When we start looking outside of the large distributors, that’s when you run into problems," said Dr. Cobb, managing partner at Frontier Cancer Center in Billings, Montana, and former president of the Community Oncology Alliance.

When a drug is procured and given directly to a patient by a physician – as is the case with many oncology drugs – "the only safe move is for the physician to follow U.S. law, because then the physician is liable," Dr. Cobb said in an interview.

"When you’re an oncologist administering these kinds of drugs, you just can’t take that chance. You want to make sure that what you give the patient is exactly the drug and exactly the dosage."

In its first fake-bevacizumab warning, the FDA said that 19 U.S. medical practices obtained the counterfeit from Quality Specialty Products (QSP), a foreign supplier also known as Montana Health Care Solutions. QSP products are also distributed by Volunteer Distribution in Gainesboro, Tenn.

The agency specified medications purchased from a foreign distributor named Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. (BDMI) in its more recent letter alerting oncologists to the second counterfeit.

"Packaging or vials found in the [United States] that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit," the agency wrote. The counterfeit version of Altuzan contains "no active ingredient."

Other drugs already obtained from these sources are also suspect, according to the letter. "Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA," the agency said.

What the FDA Wants Physicians to Do

The FDA advised physicians to stop using these products and to contact the FDA. The products should be retained and securely stored until further notice by the FDA. The agency recommends that physicians take the following actions:

• Report adverse events related to the use of suspect injectable cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

• Verify that a supplier is licensed in a particular state by going to the Drug Integrity and Supply Chain Security section of www.fda.gov for a list of state websites and contacts where this information can be found.

• Report suspected counterfeit products to the FDA Office of Criminal Investigations (OCI) at 800-551-3989, or by e-mail to [email protected].

Dr. Bloche and Dr. Cobb said they have no relevant conflicts of interest.

The Food and Drug Administration has identified another batch of counterfeit bevacizumab in the United States, bringing with it concerns for physicians about their legal liability in the complex world of foreign-supplied drugs.

Agency lab tests confirmed that vials of Roche’s Altuzan 400 mg/16mL – a brand of bevacizumab approved in Turkey – contain no active ingredient, the FDA announced early in April. The only bevacizumab brand approved in the United States is Avastin, a product distributed by Roche-owned Genentech.

Subsequently, the agency sent letters to specific physicians in 13 states, who are believed to have purchased medications from foreign or unlicensed suppliers that sold illegal prescription medications. These medical practices "are putting patients at risk of exposure to medications that may be counterfeit, contaminated, improperly stored and transported, ineffective, and dangerous," the agency warned in the letters.

"Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States. ... In virtually all cases, purchasing unapproved prescription drugs from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal," it advised the recipients.

Physicians Could Face Malpractice Suits

This language raises questions about physician liability when drugs are obtained from foreign distributors that have not been approved by the FDA. Not only do concerns about safety come into play, but intellectual property rights do as well, according to Dr. Maxwell Gregg Bloche, who is a physician, a professor of law, and codirector of the Georgetown–Johns Hopkins Joint Program in Law and Public Health.

Dr. Bloche emphasized a distinction between "the vast majority of prescriptions, which are not being supplied in the office" and those such as bevacizumab that are delivered in the context of a medical practice. In the former, the physician – acting as an enforcer of intellectual property law – could be acting against the interests of patients who might suffer terrible health consequences as a result of not being able to afford the drug. "However, when it comes to known counterfeit drugs that could be seriously dangerous, the physician’s role is to safeguard the patient," he said in an interview.

Adding complexity to the situation is an array of FDA-approved foreign suppliers, those foreign companies that knowingly supply dangerous or ineffective drugs, and a third category of suppliers that fall in between.

Outside the United States, there are reputable, high-quality pharmaceutical companies that offer generic drugs at much lower cost, noted Dr. Bloche. However, these companies often do not recognize U.S. patent laws. Only the name-brand drugs are legally available in the United States, until the FDA approves generic versions of those drugs.

"The physician is responsible for making medically sound judgments about risk," he said. If a patient mentions getting a prescribed drug from a foreign source, the physician can indicate that the source produces high-quality, generic versions. The patient may be breaking U.S. laws by doing so; the physician merely offered an opinion.

State malpractice laws come into play once the FDA has identified foreign suppliers that are selling counterfeit drugs – as in this round of counterfeit bevacizumab – and has warned physicians and the public, according to Dr. Bloche. Any physician who is still prescribing and/or using the drug for patients, or who tells the patient that the drug is safe, is then potentially liable.

"I think the medical malpractice law is the one that most physicians are going to be afraid of, which is a state tort law issue, said Dr. Bloche.

In recent months, one oncologist has been prosecuted on charges of distributing and receiving "misbranded and adulterated" prescription drugs in a case brought by the United States Attorney’s Office for the Eastern District of Missouri. Dr. Abid S. Nisar pleaded guilty to one count of "misbranding drugs," according to a government statement. The legal action was part of a larger case involving Neupogen, Herceptin, and Rituxan, but not Avastin, and a distributor known as Ban Dune Marketing Inc. (BDMI).

Buy From a Reputable Distributor

For practicing oncologist Dr. Patrick W. Cobb, "the main way that you know that you’re getting the right thing is to buy it from a reputable distributor. ... When we start looking outside of the large distributors, that’s when you run into problems," said Dr. Cobb, managing partner at Frontier Cancer Center in Billings, Montana, and former president of the Community Oncology Alliance.

When a drug is procured and given directly to a patient by a physician – as is the case with many oncology drugs – "the only safe move is for the physician to follow U.S. law, because then the physician is liable," Dr. Cobb said in an interview.

"When you’re an oncologist administering these kinds of drugs, you just can’t take that chance. You want to make sure that what you give the patient is exactly the drug and exactly the dosage."

In its first fake-bevacizumab warning, the FDA said that 19 U.S. medical practices obtained the counterfeit from Quality Specialty Products (QSP), a foreign supplier also known as Montana Health Care Solutions. QSP products are also distributed by Volunteer Distribution in Gainesboro, Tenn.

The agency specified medications purchased from a foreign distributor named Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. (BDMI) in its more recent letter alerting oncologists to the second counterfeit.

"Packaging or vials found in the [United States] that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit," the agency wrote. The counterfeit version of Altuzan contains "no active ingredient."

Other drugs already obtained from these sources are also suspect, according to the letter. "Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA," the agency said.

What the FDA Wants Physicians to Do

The FDA advised physicians to stop using these products and to contact the FDA. The products should be retained and securely stored until further notice by the FDA. The agency recommends that physicians take the following actions:

• Report adverse events related to the use of suspect injectable cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

• Verify that a supplier is licensed in a particular state by going to the Drug Integrity and Supply Chain Security section of www.fda.gov for a list of state websites and contacts where this information can be found.

• Report suspected counterfeit products to the FDA Office of Criminal Investigations (OCI) at 800-551-3989, or by e-mail to [email protected].

Dr. Bloche and Dr. Cobb said they have no relevant conflicts of interest.

The Food and Drug Administration has identified another batch of counterfeit bevacizumab in the United States, bringing with it concerns for physicians about their legal liability in the complex world of foreign-supplied drugs.

Agency lab tests confirmed that vials of Roche’s Altuzan 400 mg/16mL – a brand of bevacizumab approved in Turkey – contain no active ingredient, the FDA announced early in April. The only bevacizumab brand approved in the United States is Avastin, a product distributed by Roche-owned Genentech.

Subsequently, the agency sent letters to specific physicians in 13 states, who are believed to have purchased medications from foreign or unlicensed suppliers that sold illegal prescription medications. These medical practices "are putting patients at risk of exposure to medications that may be counterfeit, contaminated, improperly stored and transported, ineffective, and dangerous," the agency warned in the letters.

"Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States. ... In virtually all cases, purchasing unapproved prescription drugs from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal," it advised the recipients.

Physicians Could Face Malpractice Suits

This language raises questions about physician liability when drugs are obtained from foreign distributors that have not been approved by the FDA. Not only do concerns about safety come into play, but intellectual property rights do as well, according to Dr. Maxwell Gregg Bloche, who is a physician, a professor of law, and codirector of the Georgetown–Johns Hopkins Joint Program in Law and Public Health.

Dr. Bloche emphasized a distinction between "the vast majority of prescriptions, which are not being supplied in the office" and those such as bevacizumab that are delivered in the context of a medical practice. In the former, the physician – acting as an enforcer of intellectual property law – could be acting against the interests of patients who might suffer terrible health consequences as a result of not being able to afford the drug. "However, when it comes to known counterfeit drugs that could be seriously dangerous, the physician’s role is to safeguard the patient," he said in an interview.

Adding complexity to the situation is an array of FDA-approved foreign suppliers, those foreign companies that knowingly supply dangerous or ineffective drugs, and a third category of suppliers that fall in between.

Outside the United States, there are reputable, high-quality pharmaceutical companies that offer generic drugs at much lower cost, noted Dr. Bloche. However, these companies often do not recognize U.S. patent laws. Only the name-brand drugs are legally available in the United States, until the FDA approves generic versions of those drugs.

"The physician is responsible for making medically sound judgments about risk," he said. If a patient mentions getting a prescribed drug from a foreign source, the physician can indicate that the source produces high-quality, generic versions. The patient may be breaking U.S. laws by doing so; the physician merely offered an opinion.

State malpractice laws come into play once the FDA has identified foreign suppliers that are selling counterfeit drugs – as in this round of counterfeit bevacizumab – and has warned physicians and the public, according to Dr. Bloche. Any physician who is still prescribing and/or using the drug for patients, or who tells the patient that the drug is safe, is then potentially liable.

"I think the medical malpractice law is the one that most physicians are going to be afraid of, which is a state tort law issue, said Dr. Bloche.

In recent months, one oncologist has been prosecuted on charges of distributing and receiving "misbranded and adulterated" prescription drugs in a case brought by the United States Attorney’s Office for the Eastern District of Missouri. Dr. Abid S. Nisar pleaded guilty to one count of "misbranding drugs," according to a government statement. The legal action was part of a larger case involving Neupogen, Herceptin, and Rituxan, but not Avastin, and a distributor known as Ban Dune Marketing Inc. (BDMI).

Buy From a Reputable Distributor

For practicing oncologist Dr. Patrick W. Cobb, "the main way that you know that you’re getting the right thing is to buy it from a reputable distributor. ... When we start looking outside of the large distributors, that’s when you run into problems," said Dr. Cobb, managing partner at Frontier Cancer Center in Billings, Montana, and former president of the Community Oncology Alliance.

When a drug is procured and given directly to a patient by a physician – as is the case with many oncology drugs – "the only safe move is for the physician to follow U.S. law, because then the physician is liable," Dr. Cobb said in an interview.

"When you’re an oncologist administering these kinds of drugs, you just can’t take that chance. You want to make sure that what you give the patient is exactly the drug and exactly the dosage."

In its first fake-bevacizumab warning, the FDA said that 19 U.S. medical practices obtained the counterfeit from Quality Specialty Products (QSP), a foreign supplier also known as Montana Health Care Solutions. QSP products are also distributed by Volunteer Distribution in Gainesboro, Tenn.

The agency specified medications purchased from a foreign distributor named Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. (BDMI) in its more recent letter alerting oncologists to the second counterfeit.

"Packaging or vials found in the [United States] that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit," the agency wrote. The counterfeit version of Altuzan contains "no active ingredient."

Other drugs already obtained from these sources are also suspect, according to the letter. "Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA," the agency said.

What the FDA Wants Physicians to Do

The FDA advised physicians to stop using these products and to contact the FDA. The products should be retained and securely stored until further notice by the FDA. The agency recommends that physicians take the following actions:

• Report adverse events related to the use of suspect injectable cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

• Verify that a supplier is licensed in a particular state by going to the Drug Integrity and Supply Chain Security section of www.fda.gov for a list of state websites and contacts where this information can be found.

• Report suspected counterfeit products to the FDA Office of Criminal Investigations (OCI) at 800-551-3989, or by e-mail to [email protected].

Dr. Bloche and Dr. Cobb said they have no relevant conflicts of interest.