FDA issues warning letter to researcher about promoting Ipsens Dysport

The U.S. Food and Drug Administration (FDA) has issued a warning to Miami Beach-based researcher Leslie Baumann, M.D., regarding promotional statements she made about Ipsen Biopharm’s (Paris) injectable frown line treatment Dysport (abobotulinumtoxinA), the FDA said in a letter.

Dr. Baumann’s promotional statements about Dysport, which were made to two magazines and NBC’s “Today Show,” were reportedly made in 2006, prior to the drug’s FDA approval. The statements were therefore in violation of the FDA’s regulations on pre-approval promotion, the agency said in its letter.

Dr. Baumann was involved as a researcher in Phase III trials of Dysport, also known as Reloxin, at the time she made the promotional statements, the FDA stated.

Dr. Baumann’s statements about Dysport included claims that its effects “last a month longer than Botox (onabotulinumtoxinA, Allergan, Irvine, Calif.),” the FDA letter cited. The FDA approved Dysport for treating forehead wrinkles and frown lines last spring. Ipsen granted distribution rights for the drug’s cosmetic use to Medicis (Scottsdale, Ariz).

Kaiser questions complexity of drug-safety programs

Kaiser Permanente is concerned that too many diverse drug safety programs will impose a burden on the healthcare system and on patients, and that this will drive up costs and limit access to therapies.

The integrated health plan wants a greater say in how the Food and Drug Administration (FDA) and drug companies design and implement these programs to ensure they don’t discriminate against certain healthcare providers and pharmacies.

In 2007, Congress expanded FDA’s authority to require drug makers to establish Risk Evaluation and Mitigation Strategies (REMS) to enhance the safe and appropriate use of marketed medicines. Most of the 80 or more approved REMS are fairly modest, only providing patients with printed medication guides that describe proper drug use.

But a growing number of these programs also include more extensive Elements to Assure Safe Use (ETASU), which tightly manage prescribing and dispensing of high-risk medicines. ETASU can involve limited distribution of the drug and certification of prescribers and pharmacists to ensure appropriate prescribing and dispensing; in some cases patients have to be tested to ensure they’re not pregnant, for example, or that the drug is not causing harmful reactions.

COST AND ACCESS QUESTIONED

Kaiser is concerned that its physicians and pharmacies will be cut out of such certification and distribution programs, and that its patients will have difficulty gaining access to needed therapies. Such requirements could increase costs for health plans and for consumers, limiting access to needed drugs and the overall benefits of the REMS safety program.

The problem has not been that noticeable so far because most REMS with ETASU have involved drugs for relatively small patient populations. However, FDA is considering a more involved REMS for the broad class of extended-use opioids, and might weigh such an approach for erythropoietin-stimulating agents (for red blood cell production), drugs that are expensive and widely used.

Consequently, Kaiser has formally petitioned FDA to open up its process for designing and approving REMS with ETASU. Kaiser proposes that FDA’s public advisory committees review such processes to make the proposals more transparent and to allow plans and providers to have a say. That would give Kaiser an opportunity to have its own specialty pharmacy operation included in a REMS network.

The health plan also wants to ensure that REMS programs protect the privacy of patient health information.

Fera Pharmaceuticals now shipping erythromycin ophthalmic ointment

Erythromycin ophthalmic ointment is now available after a previous market shortage, manufacturer Fera Pharmaceuticals (New York) said in a press release.

Last summer the company acquired erythromycin and six other ophthalmic ointments; during the transfer period, supplies of both erythromycin and bacitracin became very limited. Erythromycin is currently on a list of drug shortages on the U.S. Food and Drug Administration’s Web site.

Last week, Fera announced the completion of bacitracin’s manufacturing transfer and has begun shipping again to pharmacies and wholesalers.

Fera anticipates the availability of the 3.5-gram tube size of erythromycin in cartons of 24, Hospital-Pak, as well as the single 3.5-gram tube package size over the next few weeks, the company said in the release.

According to the FDA’s Web site, Bausch & Lomb (Rochester, N.Y.), which also manufactures erythromycin, is currently releasing the product in the 50 x 1 gm packaging configuration. Bausch & Lomb is also distributing limited amounts of product in the 3.5-gram tube, the FDA reported.

Abbott Receives U.S. FDA Approval for Heat-Stable Norvir® (ritonavir) Tablets

Abbott Receives U.S. FDA Approval for Heat-Stable Norvir® (ritonavir) Tablets

Abbott Submits New HIV Test to FDA for Expedited Review

Abbott Submits New HIV Test to FDA for Expedited Review

Alcon to Purchase Ophthalmic Pharmaceutical Assets from Sirion

HUENENBERG, Switzerland, Jan 18, 2010 (BUSINESS WIRE) — Alcon
(NYSE: ACL),
the world’s leader in eye care, announced today that it will purchase
the rights in the United States for two FDA-approved topical eye care
products from Sirion Therapeutics, Inc. The two products purchased are
Durezol(TM), a marketed ophthalmic corticosteroid approved for the
treatment of inflammation and pain associated with eye surgery, and
Zirgan(TM), a recently approved antiviral for the treatment of acute
herpetic keratitis (corneal ulcers). In addition to these marketed
products, Alcon also acquired the global rights, excluding Latin
…

Biologics can treat some cases of inflammatory bowel disease

INFLAMMATORY BOWEL DISEASE (IBD) includes ulcerative colitis and Crohn’s disease, two distinct conditions with similar symptoms, in which the intestines become inflamed, probably as a result of the body’s immune reaction mobilized against intestinal tissue. Ulcerative colitis affects the colon and the rectum, while Crohn disease’s may affect any portion of the gastrointestinal tract (most often the small intestine and/or the colon.) Symptoms typically include diarrhea, abdominal pain, nausea and vomiting, fever and weight loss. Sometimes there are associated complaints such as arthritis or skin problems.

Most patients have sporadic symptoms. About 20% to 25% have frequently relapsing disease, or chronically active disease. Drugs to treat IBD include mesalamine (a substance that helps control inflammation), antibiotics, corticosteriods, and immunosuppressants.

“For patients with mild to moderate disease, initial treatment would depend on their specific condition,” says Bruce Sands, MD, MS, vice chair of the American Gastroenterological Association Institute. “A person with moderate disease might have diarrhea three or four times a day, and some degree of urgency and belly pain, but they can take in adequate nutrition, and they are able to function in daily life.”

However, a significant proportion of patients, perhaps 15% to 20%, do not respond to conventional treatment. The introduction of tumor necrosis factor (TNF) inhibitors in 1999 dramatically altered treatment for these patients.

These medications are biologic substances that can locate and bind to the specific molecules involved in causing inflammation. Today, three TNF inhibitors are approved by the FDA for treatment of moderate to severe Crohn’s disease that has not responded to other drugs: Cimzia (certolizumab pegol), Humira (adalimumab), and Remicade (infliximab).

Remicade is also approved for treatment of moderate to severe ulcerative colitis that has not responded to other therapies. Tysabri (natalizumab) a monoclonal antibody, has been approved by the FDA for treatment of moderate to severe Crohn’s disease that has not responded sufficiently to other treatments.

“TNF inhibitors were a completely different type of agent that could produce a response in patients who had been refractory to all existing therapies,” says Dr. Sands. “Before the advent of TNF inhibitors, I had patients who were completely homebound by the disease. Not every patient responds, and some have a partial response, but in many cases patients were able to return to work and a normal lifestyle.”

These medications have side effects, which may include the risk of infection or rare cases of lymphoma, says Dr. Sands. When patients have mild symptoms, typically those medications are not recommended.

MAKING CHOICES

MCOs often rely on a prior authorization process for TNF inhibitors.

“We provide a number of options for members who have IBD, and we ask them to work with their physicians for a choice of agent,” says Brian Sweet, PharmD, MBA, chief pharmacy officer for WellPoint.

At WellPoint, pharmacists answer front line calls for prior authorizations and work with physicians to obtain documentation.

“If appropriate documentation is not met, then [the request] is sent to a medical director for medical review.” he says. “The medical director is the only person who can actually determine that the claim would not be paid or that the prior authorization criteria are not met.”

The prior authorization criteria WellPoint uses for TNF inhibitors for IBD treatment are aligned with FDA recommendations and the organization’s medical policy.

“Remicade is the only biologic approved for treatment of ulcerative colitis,” says Sweet. “If the doctor demonstrates the patient has not responded to conventional treatments, then Remicade would be approved for ulcerative colitis.”

Humira, Cimzia, and Remicade have been approved for Crohn’s disease, and Tysabri has been approved for moderate to severe Crohn’s disease that has not responded to conventional therapies or to TNF inhibitors

“There are significant safety concerns with Tysabri, related to the risk of PML [progressive multifocal leukoencephalopathy], so in that case there is an additional step edit,” says Sweet.

Sometimes the claims are paid as a medical claim, and sometimes as a pharmacy claim. Criteria must be consistent to ensure consistent access across the organization, he says. Specialty pharmaceuticals often are placed in the highest tier of the formulary and require the highest out-of-pocket costs.

“That’s because we want to ensure an appropriate amount of member coinsurance, so they understand the expense of these agents,” says Sweet.

Coinsurance for these medications is about $50 on average, although it may vary widely across different benefit designs.

This article is based on information supplied by The Medical Letter ( www.medicalletter.org), a non-profit organization that publishes newsletters offering critical appraisals of new drugs and comparative reviews of older drugs. The Medical Letter is completely independent of the pharmaceutical industry. It is supported entirely by subscription sales and accepts no advertising, grants or donations. Institutional site license inquiries can be sent toinfo@medicalletter.org. [info@medicalletter.org.]

FDA prioritizes drug safety, expects industry to be proactive

Early last month, the FDA launched the Safe Use Initiative, which aims to create and facilitate public and private collaborations within healthcare to reduce preventable harm associated with medication misuse, errors and other medication-related problems.

Through this initiative, the FDA hopes to improve upon current approaches, many of which were put in place over the last century as reactionary measures to specific needs or emergencies.

“Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems.” says FDA Commissioner Margaret A. Hamburg, MD, “The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries.”

Specifically, the initiative plans to unite federal agencies such as the FDA, Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control (CDC) and Drug Enforcement Agency (DEA), together with professional societies, pharmacies, hospitals, drug developers, manufacturers and distributors, as well as patients and their representative organizations in order to manage medication risk.

“All participants in the healthcare community have a role to play in reducing the risks and preventing injuries from medication use.” says Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research.

At present, millions of Americans require prescription and/or over-the-counter (OTC) medications to improve or preserve their health; with as many as 3 billion prescriptions written annually. As a result of this vast use of medications, it is estimated that at least 1.5 million preventable adverse drug events occur annually, resulting in hundreds of thousands of injuries and deaths.

Adverse events from medication use have been linked to more than 4 million visits to emergency departments, provider offices or other outpatient settings and greater than 100,000 hospitalizations each year. According to FDA officials, “many injuries associated with medication use could be prevented with currently available knowledge.”

In fact, current estimates suggest anywhere from 11% to 50% of injuries could be preventable.

During the initiative’s first year, the FDA plans to implement a small number of safety programs. Some key interventions include evaluating consumer medication information; communicating the risk of overexposure to acetaminophen; safeguards for alcohol-based surgical preparations and avoiding contamination of multiple use medication vials. FDA intends to hold a series of public meetings to gather feedback.

Abbott Seeks FDA Approval of New Dosage Strengths of SIMCOR® (niacin extended-release/simvastatin)

Abbott Seeks FDA Approval of New Dosage Strengths of SIMCOR® (niacin extended-release/simvastatin)

Steris Responds to FDA’s SS1 Warning

Medical manufacturer Steris says it disagrees with a safety alert the U.S. Food and Drug Administration issued last week, in which the agency urged users of the Steris System 1 to find an alternative method for sterilizing and disinfecting their instruments.

Besides stating that the modified version of the SS1 has not received FDA approval, the safety alert says that the agency has received reports of operational malfunctions in the popular tabletop liquid chemical reprocessor that could cause such “serious injuries” as patient infections. If you have an acceptable alternative to the SS1, the FDA says, you should transition to that alternative.

Steris responded yesterday by saying that the SS1 is safe and effective when used as directed. “We are working to engage in further dialogue with FDA about this matter,” says the company.

Steris notes that there has not been a documented case of infection directly caused by a SS1 when certified health professionals have followed proper guidelines and instructions.

The SS1 was introduced in 1988. More than 23,000 units have been used in more than 5,000 hospitals and clinics in the United States, sterilizing more than 300 million medical devices or about 30,000 per day. Users who have questions or require immediate assistance can contact Steris at (440) 392-7223.

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