Drug & Device News

FDA Oversight of' Compounding Pharmacies Urged

Testifying before a congressional committee on April 16, FDA Commissioner Dr. Margaret A. Hamburg said that her agency's hands had been tied by lack of regulations permitting it to impose safety standards on compounding pharmacies. These pharmacies, which traditionally custom-make drug products to meet the special needs of individuals, are overseen by the states. However, now that many of them are running larger-scale operations and shipping their products out of their home states, the chance that widespread injuries can occur when they fail to operate safely are greatly increased.

Last year, that eventuality apparently became reality when the New England Compounding Center sold injectable steroid compounds to health care facilities in several states. These doses were allegedly contaminated in the manufacturer's facility, eventually causing nearly 700 patients to contract fungal meningitis. Fifty of those people died.

In her remarks to the House Energy and Commerce Committee, Dr. Hamburg urged congressional lawmakers to extend the FDA's reach to permit it to regulate and oversee the operations of large compounding pharmacies in order to avoid large-scale health crises like the 2012 meningitis outbreak.'

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Applicants for Approval to Sell Generic Oxycontin Rebuffed

The patent on pharmaceutical manufacturer Purdue Pharma's slow-release oxycodone product, Oxycontin, was set to expire on April 16. Would-be generic manufacturers were waiting in the wings, ready to step in and sell their own competing products. However, on that same day, the FDA announced that it would not approve any generic versions of oxycodone based on Purdue Pharma's previously patented product because, since 2010, the manufacturer has been selling an altered version that is less vulnerable to abuse.

OxyContin gained notoriety' when it became popular as a recreational drug which, although designed to release its active ingredients slowly, could be crushed or made injectable for a quick and intense “high.” Now, OxyContin tablets are made using newly patented methods that make it difficult to crush or dissolve, and they cannot be as easily prepared to enable injection. With these changes to the Purdue Pharma product, the FDA concluded that all competitors' products based on original OxyContin patents are inferior, so the risks of their use outweigh their benefits to patients.

“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” explained Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research. “While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.” Although this decision is good news for the war on drug abuse, it means that those who legitimately need doctor-prescribed pain relief will not be able to access lower-cost generic alternatives to brand-name OxyContin.

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FDA Oversight of' Compounding Pharmacies Urged

Testifying before a congressional committee on April 16, FDA Commissioner Dr. Margaret A. Hamburg said that her agency's hands had been tied by lack of regulations permitting it to impose safety standards on compounding pharmacies. These pharmacies, which traditionally custom-make drug products to meet the special needs of individuals, are overseen by the states. However, now that many of them are running larger-scale operations and shipping their products out of their home states, the chance that widespread injuries can occur when they fail to operate safely are greatly increased.

Last year, that eventuality apparently became reality when the New England Compounding Center sold injectable steroid compounds to health care facilities in several states. These doses were allegedly contaminated in the manufacturer's facility, eventually causing nearly 700 patients to contract fungal meningitis. Fifty of those people died.

In her remarks to the House Energy and Commerce Committee, Dr. Hamburg urged congressional lawmakers to extend the FDA's reach to permit it to regulate and oversee the operations of large compounding pharmacies in order to avoid large-scale health crises like the 2012 meningitis outbreak.'

'

Applicants for Approval to Sell Generic Oxycontin Rebuffed

The patent on pharmaceutical manufacturer Purdue Pharma's slow-release oxycodone product, Oxycontin, was set to expire on April 16. Would-be generic manufacturers were waiting in the wings, ready to step in and sell their own competing products. However, on that same day, the FDA announced that it would not approve any generic versions of oxycodone based on Purdue Pharma's previously patented product because, since 2010, the manufacturer has been selling an altered version that is less vulnerable to abuse.

OxyContin gained notoriety' when it became popular as a recreational drug which, although designed to release its active ingredients slowly, could be crushed or made injectable for a quick and intense “high.” Now, OxyContin tablets are made using newly patented methods that make it difficult to crush or dissolve, and they cannot be as easily prepared to enable injection. With these changes to the Purdue Pharma product, the FDA concluded that all competitors' products based on original OxyContin patents are inferior, so the risks of their use outweigh their benefits to patients.

“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” explained Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research. “While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.” Although this decision is good news for the war on drug abuse, it means that those who legitimately need doctor-prescribed pain relief will not be able to access lower-cost generic alternatives to brand-name OxyContin.

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