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.

FDA Extends Time Limit Recommendations for Healthcare Facilities to Transition to Alternatives of Steris System 1

Healthcare facilities now have 18 months to fully transition to an alternative reprocessing device from the Steris System 1 processor, according to news release from the U.S. Food and Drug Administration.

Steris Corporation did not seek FDA clearance for the device, and FDA has not approved or cleared the SS1 for its labeled claims. As a result, the FDA announced in December that facilities using the devices should transition to an alternative within three to six months.

According to the FDA, the three-to-six-month recommendation was based on discussions with a number of outside constituents. However, since then, the FDA has heard from many other healthcare providers and professional organizations and believes that a three-to-six-month transition period may present significant difficulties for some healthcare facilities, which could, in turn, adversely affect patient care, according to the release.

The FDA does not expect to take regulatory action against healthcare facilities for failing to replace SS1 units within the 18-month transition period, but these facilities should be aware that the current SS1 is a misbranded as safe and effective for its labeled claims. Healthcare facilities should, therefore, transition to alternative reprocessing devices as soon as practicable, according to the release.

Read the FDA release on the Steris System 1 recall.

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.

Spectranetics Corp. Pays $4.9M to Settle Unapproved Medical Device Claims

Colorado Springs, Colo.-based Spectranetics Corp., a medical device manufacturer, has agreed to pay the United States $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims that the company illegally imported unapproved medical devices and provided them to physicians for use in patients, conducted a clinical study in a manner that failed to comply with federal regulations and promoted certain products for procedures for which the company had not received Food and Drug Administration approval or clearance, according to a news release from the U.S. Department of Justice.

The company manufactures, distributes and sells certain medical lasers and peripheral devices for those lasers, such as lead wires that guide the lasers through vascular tissue and catheters that carry and contain the lasers inside the veins, including, specifically, the CVX-300 Medical Laser and the CliRpath Turbo Laser Catheter, the TURBO Elite Laser Ablation Catheter, and the TURBO-Booster Laser Guide Catheter, according to the release.

Spectranetics has also entered into a civil settlement agreement and a non-prosecution agreement with the United States as well as a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. According to the non-prosecution agreement, company officers and employees imported unapproved medical devices from overseas manufacturers and distributed those devices for use in human patients and failed to meet its reporting obligations to FDA regarding a study named CORAL and another associated study in connection with the devices listed above.

Under the terms of the agreement, Spectranetics has accepted responsibility for its conduct, has instituted remedial measures to prevent this conduct in the future and will continue to cooperate in the ongoing criminal investigation. As a result, Spectranetics will not be criminally prosecuted for this conduct, according to the release.

The civil settlement agreement states that Spectranetics caused false claims to be submitted to the Medicare Program during portions of the time period from 2003-2008.

Read the DOJ release about Spectranetics Corp.

Boston Scientific Receives CE Mark, FDA 510(k) Clearance for WallFlex Fully Covered Esophageal Stent

Boston Scientific Corp. has received 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval to market its WallFlex Fully Covered Esophageal Stent for the treatment of malignant esophageal strictures caused by tumors in patients with resectable or non-resectable esophageal cancer, according to a Boston Scientific news release.

Patients with obstructions due to esophageal cancer may have difficulty swallowing, resulting in severely limited quality of life, and complete blockages of the esophagus can prevent liquid consumption, according to the release. The WallFlex Esophageal Stent allows physicians to re-establish patency of the esophagus, enabling resumption of oral intake.

The WallFlex Fully and Partially Covered Stents employ a proprietary Permalume silicone covering designed to prevent tumor ingrowth, seal concurrent esophageal fistulas and help reduce food impaction, according to the release. The stents’ progressive-step, flared ends are designed to reduce the risk of migration and may assist in anchoring the fully covered stent within the esophageal lumen. The multiple wire-braided construction is engineered to allow the stent to adjust to forces within the esophagus such as peristalsis and strictures. The WallFlex Fully Covered Stent may be reconstrained up to 75 percent deployment.

Read the Boston Scientific release about the WallFlex Fully Covered Esophageal Stent.

FDA Launches Study of LASIK Safety Issues, Issues Warning Letter to 17 LASIK Centers

The U.S. Food and Drug Administration has launched a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis, a surgical procedure that uses an excimer laser to permanently change the shape of the cornea, according to an FDA news release.

The goal of the study, called the LASIK Quality of Life Collaboration Project, is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.

The FDA also announced that it issued warning letters to 17 LASIK surgery centers after inspections revealed inadequate adverse event-reporting systems at the centers. The inspections, however, did not identify problems with the use of the LASIK devices at these facilities, according to the release.

The study will take place in three phases. Phase one, which began in July, was the launch of a Web-based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure. Phase two will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active-duty population treated at the Navy Refractive Surgery Center. Phase three will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases two and three have yet to begin, according to the report.

The results of the study will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. The FDA stated that if any of the factors identified by the study related to the safety or effectiveness of the lasers used in LASIK surgery, it will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery, according to the release.

Read the FDA’s release on the LASIK Quality of Life Collaboration Project.

Covidien Receives FDA Clearance for Mallinckrodt TaperGuard Evac Endotracheal Tube

Covidien, a global provider of healthcare products and an innovator in mechanical ventilation and respiratory care devices, received 510(k) clearance from the U.S. Food and Drug Administration to market its Mallinckrodt TaperGuard Evac endotracheal tube, according to a Covidien news release.

The TaperGuard endotracheal tube reduces leakage past the cuff by at least 81 percent compared with the Mallinckrodt Hi-Lo endotracheal tube, potentially reducing the risk of post-surgical complications that may be caused by aspiration of fluids into the lungs, according to the report.

“The TaperGuard endotracheal tubes offer significant advantages for anesthesiologists, surgeons and their patients,” Jim Willett, general manager and vice president of airway and ventilation for Covidien, said in the report. “This FDA 510(k) clearance means more physicians will gain awareness of this innovative product and incorporate its use into their procedures, confirming Covidien’s mission to provide solutions designed to improve patient safety, medical efficacy and healthcare efficiency.”

Read the Covidien release about Mallinckrodt TaperGuard Evac Endotracheal Tubes.

Unomedical Recalls Certain Manual Pulmonary Resuscitators

McAllen, Texas-based Unomedical is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitators, manufactured between July 2002 and March 2008, according to a news release from the U.S. Food and Drug Administration.

The recall is being conducted because of a potential malfunction of certain units of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death, according to the release.

This recall does not impact any MPRs manufactured after March 2008.

Unomedical has set up a Web page with a list of affected lot numbers, guidance (diagram and photos) to allow customers to identify products subject to the recall in the event that the customer has already removed the primary product packaging and instructions on what actions to take.

In order to distinguish between the recalled product and unaffected product, customers may examine the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible, according to the release. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned to Unomedical as instructed. MPR units with a clearly visible blue retention ring are not affected and do not need to be returned.

Read the FDA’s release about the Unomedical manual pulmonary resuscitator recall.

FDA Orders Postmarket Surveillance Studies on Spinal Surgery Dynamic Stabilization Systems

The U.S. Food and Drug Administration has ordered manufacturers of certain types of pedicle screw systems, called dynamic stabilization systems, to conduct postmarket surveillance studies to collect clinical data on a number of potential safety issues, including fusion rates and frequency of additional surgeries, according to an FDA news release.

Dynamic stabilization systems are used in spinal surgery and some are intended to provide stabilizing support to the spinal column during bone fusion. According to the FDA, there is currently not enough clinical data to determine whether these dynamic stabilization systems provide enough spinal stability to allow for complete spinal fusion, as the system components may loosen, bend or break over time. If fusion does not occur, a patient’s condition could worsen and possibly require additional surgical procedures.

As a result, the FDA is requiring postmarket studies to address these potential risks for class II dynamic stabilization systems already on the market. In addition, the FDA is requesting manufacturers with new dynamic stabilization systems or components to submit clinical information for agency review prior to marketing.

The FDA has required the manufacturers of 16 dynamic stabilization systems or components on the market for spinal fusion to conduct postmarket surveillance studies, which must address the following:

• the fusion rate for dynamic stabilization systems compared to traditional stabilization systems;
• the incidence rate, severity and time course of adverse events for dynamic stabilization systems compared to traditional stabilization systems;
• the type, incidence rate and time course of subsequent surgical procedures for dynamic stabilization systems compared to traditional stabilization systems; and
• the cause of failure for dynamic stabilization systems based on analysis of all reasonable available systems that have been removed from patients, along with any association between the patient’s demographic and clinical data and the device failure.

Read the FDA release on the postmarket surveillance studies for spinal surgery dynamic stabilization systems.

FDA Issues Recommendations to Address Concerns Over Excess Radiation Exposure in CT Scans

The U.S. Food and Drug Administration has released interim recommendations for imaging facilities and providers to address concerns regarding excess radiation exposure during CT scans, which is currently under investigation by the agency, according to an FDA news release.

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