Drug & Device News

FDA Recruiting Drug Manufacturers for Pilot Import Program

The FDA is signing up drug companies for a pilot program to help it devise a system for ensuring the safety of drugs and drug components imported into the United States. The agency is asking for 100 volunteer companies to take part in the experiment that will, according to an FDA release, “assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant.” Drug company applicants may choose up to five of their products and submit them for selection in the pilot program. To take part in the program, the companies must be able to show that they maintain complete control over the drugs from the time of manufacture through entry into the United States. The incentive for manufacturers is that their qualifying pharmaceutical products can be imported more quickly.

Nigerian Plaintiffs May Sue Drug Company in U.S.

A divided U.S. Court of Appeals for the Second Circuit has revived a suit brought against Pfizer by 88 Nigerian families claiming their children were given the experimental drug Trovan without their consent. The experimental antibiotic, which Pfizer says it provided only to children whose parents consented, was given to 100 patients at a Nigerian hospital during a 1996 meningitis outbreak. One hundred others were given an FDA-approved drug, Ceftriaxone, as a control. Eleven children died during the testing, but Pfizer says those deaths were the result of the meningitis the children were suffering from, not the Trovan.

The plaintiffs based their right to make a claim in U.S. federal court on a 1789 law that lets foreign nationals bring suits here for violations of “the law of nations.” The lower court said the law did not confer jurisdiction on it for such claims, but the Second Circuit disagreed. Still, the case may have to be brought in Nigeria, as the Second Circuit was not asked to address the lower court's dismissal of the case on an alternative basis, forum non conveniens.

GAO Wants Stricter Premarket Approval Rules for Devices

The U.S. Government Accountability Office (GAO) issued a report in January that criticizes of the FDA's methods for approving the sale of many medical devices sold in the United States. The report says that although the FDA was supposed to tighten the rules around premarket review of new class III medical devices, it has failed to do so. Said the report's summary (posted at www.gao.gov/products/GAO-09-190), “Although Congress envisioned that class III devices would be approved through the more stringent PMA [premarket approval process] process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, this process remains incomplete.” Instead, most new class III medical devices are still being pushed onto the market through the abbreviated approval process permitted for devices that are “substantially similar” to products already on the market. The GAO has recommended that the Secretary of Health and Human Services direct the FDA Commissioner to review all medical devices and either reclassify them into the less dangerous class I or class II categories; or, if they must remain in class III, allow such devices to be approved only through the more rigorous PMA process.

Eli Lilly Settles Whistleblower Case for Record Amount

In the largest-ever settlement obtained by the United States Department of Justice, Eli Lilly & Co. has agreed to pay $800 million in civil damages and $600 million in criminal fines for, among other things, firing or pressuring to quit six pharmaceutical salesmen who voiced concerns to the company over its marketing of the anti-psychotic drug Zyprexa. The former salespeople said the drug manufacturer was pushing Zyprexa as a treatment for dementia in the elderly, although the drug was not approved for such use. In a release, the Office of the U.S. Attorney for the Eastern District of Pennsylvania stated: “Eli Lilly's management created marketing materials promoting Zyprexa for off-label uses, trained its sales force to disregard the law, and directed its sales personnel to promote Zyprexa for off-label uses. Anticipating the possiblility of resistance from primary care physicians to prescribing Zyprexa, defendant Eli Lilly specifically trained its sales representtitives on how to respond to doctors' concerns about off-label uses.”

Study Says Children in Foster Care Not Improperly Used in Drug Experiments

A study ordered by New York City's Administration for Children's Services (ACS) has largely exonerated the child welfare agency of wrongdoing following accusations that between 1985 and 2005 it subjected children in foster care to experimental HIV/AIDS drugs without their parents' permission. The study, conducted by the Vera Institute of Justice, was ordered to address not only the charge that ACS failed to get parental permission, but also allegations that the children enrolled in the 88 drug studies were chosen because they were African-American or Hispanic, and that some of them may have died because of their participation. The Vera Institute concluded, among other things, that:

• Only two of the 532 participants in the drug trials did not meet the criteria for inclusion in those tests;
• Although 80 of the 532 trial subjects died while in foster care, there was no evidence that their participation in the drug trials caused or hastened these deaths;
• ACS set high standards for allowing foster children into experimental drug trials, requiring that all of them have the possibility of benefiting, not just those in the group getting the experimental drugs;
• Parental permission was obtained in those cases in which parental rights remained intact; and
• Any apparent over-enrollment of African-American and Hispanic children in the clinical trials was the result of the fact that children of these racial and ethnic backgrounds were overwhelmingly the ones within the New York City foster care system who had been exposed to HIV/AIDS.

FDA Recruiting Drug Manufacturers for Pilot Import Program

The FDA is signing up drug companies for a pilot program to help it devise a system for ensuring the safety of drugs and drug components imported into the United States. The agency is asking for 100 volunteer companies to take part in the experiment that will, according to an FDA release, “assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant.” Drug company applicants may choose up to five of their products and submit them for selection in the pilot program. To take part in the program, the companies must be able to show that they maintain complete control over the drugs from the time of manufacture through entry into the United States. The incentive for manufacturers is that their qualifying pharmaceutical products can be imported more quickly.

Nigerian Plaintiffs May Sue Drug Company in U.S.

A divided U.S. Court of Appeals for the Second Circuit has revived a suit brought against Pfizer by 88 Nigerian families claiming their children were given the experimental drug Trovan without their consent. The experimental antibiotic, which Pfizer says it provided only to children whose parents consented, was given to 100 patients at a Nigerian hospital during a 1996 meningitis outbreak. One hundred others were given an FDA-approved drug, Ceftriaxone, as a control. Eleven children died during the testing, but Pfizer says those deaths were the result of the meningitis the children were suffering from, not the Trovan.

The plaintiffs based their right to make a claim in U.S. federal court on a 1789 law that lets foreign nationals bring suits here for violations of “the law of nations.” The lower court said the law did not confer jurisdiction on it for such claims, but the Second Circuit disagreed. Still, the case may have to be brought in Nigeria, as the Second Circuit was not asked to address the lower court's dismissal of the case on an alternative basis, forum non conveniens.

GAO Wants Stricter Premarket Approval Rules for Devices

The U.S. Government Accountability Office (GAO) issued a report in January that criticizes of the FDA's methods for approving the sale of many medical devices sold in the United States. The report says that although the FDA was supposed to tighten the rules around premarket review of new class III medical devices, it has failed to do so. Said the report's summary (posted at www.gao.gov/products/GAO-09-190), “Although Congress envisioned that class III devices would be approved through the more stringent PMA [premarket approval process] process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, this process remains incomplete.” Instead, most new class III medical devices are still being pushed onto the market through the abbreviated approval process permitted for devices that are “substantially similar” to products already on the market. The GAO has recommended that the Secretary of Health and Human Services direct the FDA Commissioner to review all medical devices and either reclassify them into the less dangerous class I or class II categories; or, if they must remain in class III, allow such devices to be approved only through the more rigorous PMA process.

Eli Lilly Settles Whistleblower Case for Record Amount

In the largest-ever settlement obtained by the United States Department of Justice, Eli Lilly & Co. has agreed to pay $800 million in civil damages and $600 million in criminal fines for, among other things, firing or pressuring to quit six pharmaceutical salesmen who voiced concerns to the company over its marketing of the anti-psychotic drug Zyprexa. The former salespeople said the drug manufacturer was pushing Zyprexa as a treatment for dementia in the elderly, although the drug was not approved for such use. In a release, the Office of the U.S. Attorney for the Eastern District of Pennsylvania stated: “Eli Lilly's management created marketing materials promoting Zyprexa for off-label uses, trained its sales force to disregard the law, and directed its sales personnel to promote Zyprexa for off-label uses. Anticipating the possiblility of resistance from primary care physicians to prescribing Zyprexa, defendant Eli Lilly specifically trained its sales representtitives on how to respond to doctors' concerns about off-label uses.”

Study Says Children in Foster Care Not Improperly Used in Drug Experiments

A study ordered by New York City's Administration for Children's Services (ACS) has largely exonerated the child welfare agency of wrongdoing following accusations that between 1985 and 2005 it subjected children in foster care to experimental HIV/AIDS drugs without their parents' permission. The study, conducted by the Vera Institute of Justice, was ordered to address not only the charge that ACS failed to get parental permission, but also allegations that the children enrolled in the 88 drug studies were chosen because they were African-American or Hispanic, and that some of them may have died because of their participation. The Vera Institute concluded, among other things, that:

• Only two of the 532 participants in the drug trials did not meet the criteria for inclusion in those tests;
• Although 80 of the 532 trial subjects died while in foster care, there was no evidence that their participation in the drug trials caused or hastened these deaths;
• ACS set high standards for allowing foster children into experimental drug trials, requiring that all of them have the possibility of benefiting, not just those in the group getting the experimental drugs;
• Parental permission was obtained in those cases in which parental rights remained intact; and
• Any apparent over-enrollment of African-American and Hispanic children in the clinical trials was the result of the fact that children of these racial and ethnic backgrounds were overwhelmingly the ones within the New York City foster care system who had been exposed to HIV/AIDS.