FDA Staff Asks President to Straighten Up Agency

The clearance or approval of medical devices that was not made in accordance with federal laws, rules and regulations needs to be revisited, according to a recent letter sent to President Barack Obama by disgruntled FDA employees. This is the second letter FDA employees have written to the president. “The culture of wrongdoing and cover-up is nothing new, but is part of a longstanding pattern of behavior,” the letter says.

FDA approves Novartis' malaria drug Coartem

Novartis’ malaria drug Coartem, which is already available in over 80 countries, has been given the thumbs-up by regulators in the USA.

The US Food and Drug Administration has approved Coartem (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilogrammes due to plasmodium falciparum, the most dangerous form of the disease. The approval was expected after an FDA advisory panel declared the treatment to be safe and effective in December.

Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said that because of concerns about resistance with currently available therapy, “it will benefit patients to have another treatment option for malaria”. Novartis says that Coartem is a highly-effective three-day therapy with cure rates of over 96%, “even in areas of multi-drug resistance”.

Novartis chief executive Daniel Vasella said that with a growing number of malaria cases in the USA due to rising travel, it is important to make artemisinin-based combination treatment such as Coartem, the most effective therapy for malaria, available to American patients as well."

Fighting malaria “is very much in America's interest and ACTs such as Coartem are important weapons against this infectious disease," said Tim Ziemer, the US government’s malaria coordinator. The Swiss major, which noted that it supplies Coartem for public sector use in Africa without profit, has to date provided more than 235 million treatments, which have helped save an estimated 600,000 lives, mostly children.

FDA Rebuffs Teva’s Citizen Petition on Generic Copaxone Filings

The FDA has declined to review a citizen petition submitted by Teva Neurosciences asking the agency not to accept applications for generic versions of the Copaxone multiple sclerosis treatment until certain conditions are met. The agency told Teva that it would be “premature and inappropriate” to review the Copaxone (glatiramer acetate) petition filed last September. In addition, the FDA didn’t address or take action on Teva’s requests in the petition, the company says in a statement.
Generic Line

FDA Reverses Course, Drugmakers Allowed to Make Morphine Solution

Patient and hospice groups’ concerns have prompted the FDA to reverse its decision that manufacturers of morphine sulfate 20-mg/mL oral solution must stop producing the pain drug. The FDA sent nine warning letters telling companies to halt production of unapproved versions of morphine, hydromorphone and oxycodone products. The FDA is now amending those letters to allow companies to make the 20-mg/mL oral solution to meet the needs of hospice patients with severe pain, CDER Deputy Director Douglas Throckmorton said.

'Unapproved' morphine to stay on market, FDA rules

WASHINGTON (CNN) -- A form of liquid morphine used by terminally ill patients will remain on the market even though it is an "unapproved drug," according to a decision by the Food and Drug Administration.

After talking with hospital and hospice organizations, which expressed concern that taking the product off the market would result in hardship for terminally ill patients and their caregivers, the agency decided to extend the usage of morphine sulfate oral solution 20 mg/ml.

The agency wants to ensure there is shortage of the drug while patients wait for an approved product to take its place.

"While the FDA remains committed to ultimately ensuring that all prescription drugs on the market are FDA approved, we have to balance that goal with flexibility and compassion for patients who have a few alternatives for the alleviation of their pain," Dr. Douglas Throckmorton, deputy director of the FDA's Center for drug Evaluation and Research, said Thursday.

"In light of the concerns raised by these patients and their health-care providers, we have adjusted our actions with regard to these particular products."

Last month, the FDA sent warning letters to nine companies telling them to stop manufacturing 14 unapproved narcotics that are widely used to treat pain.

Seven of those companies made or distributed the oral morphine.

The morphine elixir is widely used by terminal patients in hospital and home hospice care settings and is manufactured by Lehigh Valley Technologies Inc., Mallinckrodt Inc. Pharmaceuticals Group, Boehringer Ingelheim Roxane Inc. and Cody Laboratories, Inc.

In its warning letter last month, the agency gave the companies 60 days to stop manufacturing the drug before enforcement action was taken.

Thursday's announcement did not prompt immediate reactions from the companies. A spokesman for Cody Laboratories said the firm did not have all the details of the decision. Other companies did not immediately return calls from CNN.

The FDA estimates there are several thousand drugs, mostly older products, marketed illegally without FDA approval in this country. Once an illegally marketed drug is identified, enforcement action begins because the agency does not have information on the quality of these drugs and has not had an opportunity to approve their labeling. In 1976 the agency began a program to bring companies manufacturing these drugs into compliance.

Thursday's announcement applies only to the morphine sulfate elixir 20mg/ml, and the warning letters sent to the other product manufacturers are still in effect.

Currently there are no approved morphine sulfate oral solution 20mg/ml products on the market. Until there are, the FDA says it will allow companies making and distributing the unapproved drugs to continue, until 180 days after any company receives approval to manufacture a new morphine replacement drug of the same dosage.

The FDA says it expects all companies marketing unapproved drugs to submit the necessary applications to get approval for those drugs