FDA to study phone number to report side effects

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Posted on 25th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/25/2008

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) _ The Food and Drug Administration plans to interview more than 1,500 consumers to decide whether television drug advertisements should urge patients to report side effects.

The regulatory agency is considering requiring TV promotions to carry a toll-free number where patients can report serious problems with their medication. However, some critics argue the toll-free number could distract viewers from other important safety information about the drugs.

Print advertisements already include contact information for the FDA, as required by a law passed last September. The legislation ordered the FDA to report to Congress by late March whether that information should also be mandatory for TV ads.

But the agency requested more time to complete its work and is expected to soon begin a formal study of the question — well over a year after the drug safety legislation was signed into law.

On Tuesday the agency laid out plans for a large-scale study to assess whether adding instructions about reporting side effects would overwhelm viewers who are already being bombarded by medical information.

Pharmaceutical “ads are already quite dense when compared with ads for other products,” the agency states in documents posted online. “The risk information should not be compromised by the addition of the toll-free statement.”

Drug promotions are already required to list a drug’s benefits and risks.

For its study, the FDA will show ads for a fictitious blood-pressure drug to 1,600 consumers, who would then be interviewed to see how much of the information they understood. Specifically, researchers will assess how the placement, time and wording of the statements affects comprehension.

Regulators did not say when they would launch the study, but the FDA said it would accept comments on the proposal for the next two months.

The Pharmaceutical Research and Manufacturers of America has not yet taken a stance on the issue. However, the group — which represents Merck & Co. Inc., Pfizer Inc., Wyeth and other drugmakers — supported adding the language about side effects to print ads.

TV promotions have become a cornerstone of the pharmaceutical business since regulators opened the floodgate a decade ago. Companies spent roughly $3.5 billion on commercials last year.

But some lawmakers and consumer advocates say the advertisements can encourage over-prescribing of medications before all their side effects are known. By encouraging patients to report negative reactions to FDA, they hope regulators will be able to catch drug safety problems sooner.

By the time the FDA completes its study of the toll-free number, policymakers in the now Democrat-dominated Washington may have already moved ahead with even stricter regulations.

Rep. Rosa DeLauro, D-Conn., introduced a bill this spring that would ban consumer-directed advertisements during the three years after a new drug’s launch. The proposal is aimed at limiting the use of new drugs until they have been demonstrated safe.

The legislation would also require drugmakers to mount public awareness campaigns about the risks of certain types of drugs. DeLauro is expected to reintroduce the measure next year.

“The FDA has important drug oversight responsibilities, and the push to promote new drugs and devices should not get in the way,” DeLauro said, upon releasing the bill.

Copyright 2008 The Associated Press.

Cardinal pays $34M to settle substance claims

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Posted on 2nd October 2008 by Gordon Johnson in Uncategorized

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Date: 10/2/2008 8:16 PM

WASHINGTON (AP) _ Cardinal Health Inc. will pay $34 million to settle claims that it failed to report suspicious sales of controlled substances, the Department of Justice said on Thursday.

Cardinal, one of the nation’s largest distributors of pharmaceutical drugs, reached an agreement with seven U.S. Attorney’s Offices and the Drug Enforcement Agency to pay $34 million in civil penalties for alleged violations of its obligations under the Controlled Substances Act.

Federal regulators say despite earlier warnings, Cardinal failed to report to the DEA suspicious orders of hydrocodone that it then distributed to pharmacies that filled illegitimate prescriptions from rogue Internet pharmacies.

All manufacturers and distributors are required by law to have a system in place to monitor and report suspicious orders of controlled substances. DEA Acting Administrator Michele M. Leonhart said Cardinal’s “negligent conduct contributed to our nation’s serious pharmaceutical abuse problem.”

Cardinal Health said in a statement released later Thursday that the settlements will result in reinstated licenses to distribute controlled substances from the company’s distribution centers in Auburn, Wash., Lakeland, Fla. and Swedesboro, N.J. The company said it was making the $34 million payment without admitting any wrongdoing.

“Protecting the integrity of the pharmaceutical supply chain is a responsibility we take very seriously, and preventing prescription drug abuse is a public policy goal that Cardinal Health fully supports,” Cardinal Health’s Chief Executive R. Kerry Clark said in a statement.

Copyright 2008 The Associated Press.

FDA: No quick decision on cold medicines for kids

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Posted on 2nd October 2008 by Gordon Johnson in Uncategorized

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Date: 10/2/2008 2:00 PM

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) _ A top government health official rejected the idea of an immediate ban on cough and cold medicines for young children, saying it might cause unintended harm.

Food and Drug Administration officials at a public hearing Thursday said they need to gather more data on whether over-the-counter remedies are safe and effective for children ages 2-6.

The FDA is also worried that a ban — as sought by leading pediatricians’ groups — might only drive parents to give adult medicines to their youngsters.

“That is a concern for us,” said Dr. John Jenkins, who heads the FDA’s Office of New Drugs. “We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation.”

With a new cold season coming, pediatricians are urging the government to demand a recall of over-the-counter cough and cold medicines for children younger than 6. The effectiveness of the medicines in children was never scientifically established, critics say, and problems with the drugs send thousands of kids to the emergency room every year.

“When a treatment is ineffective, its risks — unless zero — always exceed its benefits,” Dr. Michael Shannon of Children’s Hospital in Boston told the FDA panel.

The FDA this year warned against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers — and officials are not giving a timetable for a decision.

U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.

But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.

The industry says OTC medicines have been used for decades in treating kids’ colds and are safe for those older than 2. Nonetheless, manufacturers are planning to carry out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.

FDA advisers said that was not enough and recommended that the drugs not be used for children younger than 6. An expert panel said children older than 2 could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.

It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.

Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.

The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.

The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.

“The data clearly show a majority of adverse events are direct result of misuse of our products,” said Linda Suydam, who heads the industry group.

Baltimore health commissioner Dr. Joshua Sharfstein sought to reassure FDA officials worried about unintended consequences if the government moves to restrict the medications and parents start dispensing adult drugs to their preschoolers. Sharfstein said the state of Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.

“The feared increases in poisonings simply did not happen,” said Sharfstein. “In fact, the opposite occurred.”

Copyright 2008 The Associated Press.

Cephalon to pay $425M for improper drug marketing

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Posted on 30th September 2008 by Gordon Johnson in Uncategorized

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Date: 9/29/2008 6:28 PM

By MARYCLAIRE DALE
Associated Press Writer

PHILADELPHIA (AP) _ Drug maker Cephalon Inc., completing a previously announced settlement, will pay $425 million for illegally marketing a highly addictive lollipop painkiller and two other drugs for non-approved uses.

Federal prosecutors also announced Monday that Cephalon, as planned, will plead to a criminal misdemeanor for its off-label marketing.

“This company … put patients at risk for nothing more than the bottom line,” Acting U.S. Attorney Laurie Magid said at a news conference.

Doctors can prescribe drugs for uses other than what has been approved by the U.S. Food and Drug Administration, but pharmaceutical companies cannot promote such “off-label” use in their marketing.

One of Cephalon’s drugs, Actiq, was marketed to doctors for maladies including migraines and injuries when the fentanyl lollipop is a highly addictive narcotic approved only for cancer patients with severe pain, authorities said.

Cephalon encouraged off-label marketing at lavish physician-education conferences and through its compensation and bonus structure, authorities said. The company also had its sales force call on doctors who would not normally prescribe the three drugs, they said.

The off-label use proved harmful and even fatal at times, Magid said. However, the settlement does not encompass any individual cases.

Cephalon disclosed the tentative settlement last November. The Frazer-based company has signed an agreement to plead guilty to one misdemeanor count of distribution of misbranded drugs.

Cephalon also marketed Gabitril, an anti-epilepsy drug, for anxiety, insomnia and pain, authorities said. Provigil, which is approved for narcolepsy, was marketed for fatigue, among other things, they said.

The $425 million settlement includes a $375 million civil settlement, a $40 million criminal fine and $10 million in criminal forfeiture, prosecutors said.

Whistleblowers — former Cephalon sales representatives disturbed by the company’s practices — will share $46.5 million from the settlement.

Much of the money recovered will be shared by state and federal Medicaid programs that paid the tab for many of the prescriptions. Sales of Actiq soared from $50 million to $500 million from 2001 to 2006, authorities said.

Prosecutors considered charging the company with a felony, but agreed to a misdemeanor in part to preserve the company’s ability to sell the drugs to patients who need them, Magid said.

“We are pleased to have these long-standing matters behind us, while preserving our ability to participate in all federal and state health care programs, thereby maintaining the access of patients in those programs to our medications,” Jerry Pappert, Cephalon’s executive vice president and general counsel, said in a statement Monday.

Cephalon will also pay an estimated $12 million in interest.

Copyright 2008 The Associated Press.

FDA cracks down on eye wash and skin cream

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Posted on 26th September 2008 by Gordon Johnson in Uncategorized

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Date: 9/23/2008 12:23 PM

WASHINGTON (AP) _ Federal officials on Tuesday launched a crackdown against several companies that market an eye wash and a widely used skin cream without government approval, saying these prescription medications could pose risks.

The eye wash, known as a balanced salt solution, is used to keep the eyes moist during surgery. Two companies, Alcon Laboratories and Akorn, Inc. have versions that are officially approved by the Food and Drug Administration, and are not affected, the FDA said in a public notice.

But three other firms are selling similar types of eye wash without federal validation of their safety and effectiveness, said Deborah Autor, who directs the FDA’s unapproved drugs initiative. They are B. Braun, Baxter, and Hospira, she said.

The skin cream contains an enzyme called papain, derived from the tropical papaya plant. It is used for treating skin ulcers from diabetes and other causes. Although such products have been used for more than 100 years, the FDA said there are no approved versions on the market. About a dozen companies market such creams in a lucrative business worth about $50 million a year.

The agency said it has received more than 300 reports of serious reactions to the eye wash, and about 40 reports on the papaya creams, including some that said the ointment was of no help to patients and others describing life-threatening allergic reactions.

Companies making the unapproved products must file for FDA approval, or cease production by Nov. 24. Violators face FDA seizures and other legal action.

Unapproved drugs, many of which pre-date federal regulation, are a continuing problem for the FDA. The agency estimates that about 2 percent of all prescriptions written each year are for unapproved drugs, or about 72 million scripts.

Copyright 2008 The Associated Press.