Drug & Device News

FDA Will Use Internet to Speed Communications When Safety Concerns Develop

The U.S. Food and Drug Administration (FDA) has created a new Web-based information source to inform medical providers and patients about safety issues that arise soon after newly approved drugs and biologics have entered the market. According to an FDA release, the Web site will be helpful because “[s]ome side effects may not become apparent until after a medicine has been approved and becomes available to a larger, more diverse population than the patients who participated in clinical trials that supported approval.”

The new side-effect summaries will be based on reports made by manufacturers, health care providers, consumers and others to the FDA's Adverse Event Reporting System (AERS) and the Vaccine Adverse Event Reporting System, as well as from information obtained from medical literature and ongoing drug studies. Information in this system may not always be up to date, however, because the law requiring the FDA to communicate with the public about ongoing safety monitoring (Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) requires only that the agency prepare the safety summaries within 18 months after a product's approval, or after it has been used by 10,000 patients, whichever comes later.

Fed Circuit Affirms Ruling That There's No Link Between Autism and Vaccine

The U.S. Court of Appeals for the Federal Circuit on Aug. 27 upheld lower court findings that reject a causal connection between childhood vaccines and the onset of autism. The ruling came in Cedillo v. Secretary of Health and Human Services, which was the first of a series of test cases heard by special masters for the U.S. Court of Federal Claims in 2007. The claims court picked several such cases to test different theories of causation advanced in the roughly 5,000 cases alleging a link to autism filed under the National Childhood Vaccine Injury Act of 1986. Said the court, “We see no legal error in the standards applied by the special master” in determining there was no causal connection between the mercury-based preservative in the measles-mumps-rubella vaccine administered to Michelle Cedillo in 1995 and the autism and retardation symptoms she began to show afterward. The claims court last year upheld the special master's findings in the case, and this Federal Circuit decision affirmed that ruling.

Crowded Airwaves Hampering Breakthrough Device's Introduction

The Alfred Mann Foundation, a nonprofit organization that develops new technologies to help the medically impaired, is seeking permission from the Federal Communications Commission and the National Telecommunications and Information Administration to use certain bandwidths on the already crowded public airwaves. The foundation wants access to the four specific bandwidths that will best work on their muscle stimulation devices, which transmit pulses to the muscles of stroke and spinal injury patients, allowing them to move paralyzed limbs. Unfortunately, this innovative technology might be subject to interference from others using these same frequencies, including the Department of Defense and commercial land mobile radio carriers. These users fear that they will become subject to new regulatory restrictions if the device's sponsors get the go-ahead and their transmissions do prove to affect the implants. Still, the potential impact of the new medical technology on the lives of those who have been paralyzed is undeniable. Says Cheryl Tritt, a partner at Wilkinson Barker Knauer in Washington who represents the foundation, “This technology is so compelling. It's not like we're talking about garage-door openers. If we don't get access to spectrum, the technology doesn't get introduced, which would be a terrible shame for millions of people. We really need to find a way to make this work.” The devices in question are small microstimulators that are injected directly into muscles next to a peripheral nerve. The patient carries a master control unit, which directs the microstimulators to deliver electric pulses in a coordinated sequence, compelling their arms or legs to replicate the natural movements of these limbs.

Botox Maker to Pay $600 Million to Settle Off-Label Use Charges

Allergan, Inc. said that it has agreed to pay $600 million in criminal and civil penalties and plead guilty to one misdemeanor count of “misbranding” its drug Botox as part of a global settlement with the federal government over off-label uses of the drug. As part of the plea deal, the Irvine, CA.-based drug company agreed to drop its First Amendment legal action against the U.S. government. This action, filed last fall, contended that the government's legal position ' that it's a crime for a drug company to communicate truthful information to physicians about off-label uses of its products ' violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act.

FDA Will Use Internet to Speed Communications When Safety Concerns Develop

The U.S. Food and Drug Administration (FDA) has created a new Web-based information source to inform medical providers and patients about safety issues that arise soon after newly approved drugs and biologics have entered the market. According to an FDA release, the Web site will be helpful because “[s]ome side effects may not become apparent until after a medicine has been approved and becomes available to a larger, more diverse population than the patients who participated in clinical trials that supported approval.”

The new side-effect summaries will be based on reports made by manufacturers, health care providers, consumers and others to the FDA's Adverse Event Reporting System (AERS) and the Vaccine Adverse Event Reporting System, as well as from information obtained from medical literature and ongoing drug studies. Information in this system may not always be up to date, however, because the law requiring the FDA to communicate with the public about ongoing safety monitoring (Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) requires only that the agency prepare the safety summaries within 18 months after a product's approval, or after it has been used by 10,000 patients, whichever comes later.

Fed Circuit Affirms Ruling That There's No Link Between Autism and Vaccine

The U.S. Court of Appeals for the Federal Circuit on Aug. 27 upheld lower court findings that reject a causal connection between childhood vaccines and the onset of autism. The ruling came in Cedillo v. Secretary of Health and Human Services, which was the first of a series of test cases heard by special masters for the U.S. Court of Federal Claims in 2007. The claims court picked several such cases to test different theories of causation advanced in the roughly 5,000 cases alleging a link to autism filed under the National Childhood Vaccine Injury Act of 1986. Said the court, “We see no legal error in the standards applied by the special master” in determining there was no causal connection between the mercury-based preservative in the measles-mumps-rubella vaccine administered to Michelle Cedillo in 1995 and the autism and retardation symptoms she began to show afterward. The claims court last year upheld the special master's findings in the case, and this Federal Circuit decision affirmed that ruling.

Crowded Airwaves Hampering Breakthrough Device's Introduction

The Alfred Mann Foundation, a nonprofit organization that develops new technologies to help the medically impaired, is seeking permission from the Federal Communications Commission and the National Telecommunications and Information Administration to use certain bandwidths on the already crowded public airwaves. The foundation wants access to the four specific bandwidths that will best work on their muscle stimulation devices, which transmit pulses to the muscles of stroke and spinal injury patients, allowing them to move paralyzed limbs. Unfortunately, this innovative technology might be subject to interference from others using these same frequencies, including the Department of Defense and commercial land mobile radio carriers. These users fear that they will become subject to new regulatory restrictions if the device's sponsors get the go-ahead and their transmissions do prove to affect the implants. Still, the potential impact of the new medical technology on the lives of those who have been paralyzed is undeniable. Says Cheryl Tritt, a partner at Wilkinson Barker Knauer in Washington who represents the foundation, “This technology is so compelling. It's not like we're talking about garage-door openers. If we don't get access to spectrum, the technology doesn't get introduced, which would be a terrible shame for millions of people. We really need to find a way to make this work.” The devices in question are small microstimulators that are injected directly into muscles next to a peripheral nerve. The patient carries a master control unit, which directs the microstimulators to deliver electric pulses in a coordinated sequence, compelling their arms or legs to replicate the natural movements of these limbs.

Botox Maker to Pay $600 Million to Settle Off-Label Use Charges

Allergan, Inc. said that it has agreed to pay $600 million in criminal and civil penalties and plead guilty to one misdemeanor count of “misbranding” its drug Botox as part of a global settlement with the federal government over off-label uses of the drug. As part of the plea deal, the Irvine, CA.-based drug company agreed to drop its First Amendment legal action against the U.S. government. This action, filed last fall, contended that the government's legal position ' that it's a crime for a drug company to communicate truthful information to physicians about off-label uses of its products ' violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act.