Drug & Device News

FDA to Streamline Common Review Path for Medical Devices

The Food and Drug Administration (FDA) announced Jan. 19 that it intends to implement a new 25-point plan to improve the path to market for certain medical device products. The system will include a new Center Science Council made up of senior FDA experts whose job will be to ensure timely and consistent science-based decision-making. Under the new plan, de novo review of some innovative, lower risk medical devices will also be streamlined. The changes to the submission process for 510(k)s (so-called for the section of the Federal Food, Drug, and Cosmetic Act that describes this process) are being implemented because industry players working to obtain pre-market approval for low-risk devices (such as catheters and diagnostic imaging tools) found the old system unpredictable and confusing. Consumers and health care providers criticized approvals under the old system for not being rigorous enough. Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH), says the planned changes will create “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly.” For more information on specific changes to the approval process, go to: http://www.fda.gov/About
FDA/CentersOffices/CDRH/CDRH Reports/ucm239448.htm

Breast Implants May Be Linked to Rare Cancer

Because of a possible association between them, the FDA is asking health care professionals to report to it any confirmed cases of the rare cancer anaplastic large cell lymphoma (ALCL) in women with breast implants. The agency is warning that there is a possibility of increased risk of ALCL in the scar capsules adjacent to such implants. “We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA's Center for Devices and Radiological Health, in a statement. “We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants.” The FDA plans to work over the coming months with breast implant manufacturers to help them formulate updates to their product inserts reflecting the new risk information. In the meantime, the agency recommends that doctors consider the possibility of ALCA when patients present with late onset, persistent fluid around an implant, and that they discuss this potential additional risk with patients who are considering getting breast implants.

NJ Lawmakers Gear Up to Gut Medical Marijuana Rules

Governor Chris Christie's administration's regulations governing New Jersey's three-month-old medical marijuana law came a step closer to being voided on Jan. 20 when lawmakers and others criticized the proposed rules at a public hearing. Those at the hearing were there to consider resolutions declaring that the U.S. Department of Health and Human Services' regulations clash with the legislative intent behind New Jersey's Compassionate Use Medical Marijuana Act. The resolutions take issue with several aspects of New Jersey's draft rules, including the creation of two categories of alternative treatment centers ' those that may cultivate cannabis and those that may dispense it ' and a 10% cap on the permissible level of tetrahydrocannabinol, or THC, in the medical marijuana.

Pfizer Battles Claims Brought By Unsuspecting Experiment Subjects

It has been almost 15 years since Pfizer Inc., without obtaining permission from their parents, used an experimental drug to treat Nigerian children infected with meningitis. Still, claims brought by 88 of the children's families remain in dispute, and their cases are still in the pre-trial motion phase in the U.S. District Court for the Southern District of New York. Pfizer is seeking dismissal of the actions, which it argues cannot be brought based on the Alien Tort Statute, a 1789 law that gives foreigners the right to bring tort claims in U.S. federal courts for violations of “the law of nations.” The claims were permitted to go forward in 2009 after a split panel of the U.S. Court of Appeals for the Second Circuit voted to revive the suit in their February 2009 decision in Abdullahi v. Pfizer, 562 F.3d 163 (2009). The U.S. Supreme Court declined to review the case. However, another unrelated case brought under the Alien Tort Statute was thrown out in 2010 by a different panel of the Second Circuit, with that court concluding that “corporate liability is not a discernible ' much less universally recognized ' norm of customary international law that we may apply” under the statute. Kiobel v. Royal Dutch Petroleum, 610 F.3d 111. Now, Pfizer wants the court to follow Kiobel's lead and throw the Nigerian plaintiffs' suits out. Any decision the District Court makes is likely to end up before the Second Circuit again, for clarification of the issue.

FDA to Streamline Common Review Path for Medical Devices

The Food and Drug Administration (FDA) announced Jan. 19 that it intends to implement a new 25-point plan to improve the path to market for certain medical device products. The system will include a new Center Science Council made up of senior FDA experts whose job will be to ensure timely and consistent science-based decision-making. Under the new plan, de novo review of some innovative, lower risk medical devices will also be streamlined. The changes to the submission process for 510(k)s (so-called for the section of the Federal Food, Drug, and Cosmetic Act that describes this process) are being implemented because industry players working to obtain pre-market approval for low-risk devices (such as catheters and diagnostic imaging tools) found the old system unpredictable and confusing. Consumers and health care providers criticized approvals under the old system for not being rigorous enough. Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH), says the planned changes will create “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly.” For more information on specific changes to the approval process, go to: http://www.fda.gov/About
FDA/CentersOffices/CDRH/CDRH Reports/ucm239448.htm

Breast Implants May Be Linked to Rare Cancer

Because of a possible association between them, the FDA is asking health care professionals to report to it any confirmed cases of the rare cancer anaplastic large cell lymphoma (ALCL) in women with breast implants. The agency is warning that there is a possibility of increased risk of ALCL in the scar capsules adjacent to such implants. “We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA's Center for Devices and Radiological Health, in a statement. “We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants.” The FDA plans to work over the coming months with breast implant manufacturers to help them formulate updates to their product inserts reflecting the new risk information. In the meantime, the agency recommends that doctors consider the possibility of ALCA when patients present with late onset, persistent fluid around an implant, and that they discuss this potential additional risk with patients who are considering getting breast implants.

NJ Lawmakers Gear Up to Gut Medical Marijuana Rules

Governor Chris Christie's administration's regulations governing New Jersey's three-month-old medical marijuana law came a step closer to being voided on Jan. 20 when lawmakers and others criticized the proposed rules at a public hearing. Those at the hearing were there to consider resolutions declaring that the U.S. Department of Health and Human Services' regulations clash with the legislative intent behind New Jersey's Compassionate Use Medical Marijuana Act. The resolutions take issue with several aspects of New Jersey's draft rules, including the creation of two categories of alternative treatment centers ' those that may cultivate cannabis and those that may dispense it ' and a 10% cap on the permissible level of tetrahydrocannabinol, or THC, in the medical marijuana.

Pfizer Battles Claims Brought By Unsuspecting Experiment Subjects

It has been almost 15 years since Pfizer Inc., without obtaining permission from their parents, used an experimental drug to treat Nigerian children infected with meningitis. Still, claims brought by 88 of the children's families remain in dispute, and their cases are still in the pre-trial motion phase in the U.S. District Court for the Southern District of New York. Pfizer is seeking dismissal of the actions, which it argues cannot be brought based on the Alien Tort Statute, a 1789 law that gives foreigners the right to bring tort claims in U.S. federal courts for violations of “the law of nations.” The claims were permitted to go forward in 2009 after a split panel of the U.S. Court of Appeals for the Second Circuit voted to revive the suit in their February 2009 decision in Abdullahi v. Pfizer , 562 F.3d 163 (2009). The U.S. Supreme Court declined to review the case. However, another unrelated case brought under the Alien Tort Statute was thrown out in 2010 by a different panel of the Second Circuit, with that court concluding that “corporate liability is not a discernible ' much less universally recognized ' norm of customary international law that we may apply” under the statute. Kiobel v. Royal Dutch Petroleum , 610 F.3d 111. Now, Pfizer wants the court to follow Kiobel's lead and throw the Nigerian plaintiffs' suits out. Any decision the District Court makes is likely to end up before the Second Circuit again, for clarification of the issue.