FDA Under Fire for Compounding Pharmacy Oversight Failures

The New England Compounding Center has a long history of run-ins with state, federal and independent authorities, beginning just 10 months after its 1998 opening, according to a report by the U.S. Senate's Health, Education, Labor and Pensions (HELP) Committee. Now the FDA is under scrutiny for its slow response to the initial inspections, taking 2 years to send a 2006 warning letter to Barry Cadden, RPh, NECC's director of pharmacy and part-owner.

The first enforcement action against NECC, for "including blank prescriptions in solicitations to practitioners, a practice that violated [Massachusetts] law," was resolved when the Massachusetts Board of Registration in Pharmacy issued "a warning ... in a private non-disciplinary advisory letter," according to the HELP report.

The FDA first inspected NECC in 2002, when the same drug at issue in the current outbreak - methylprednisolone acetate - was a suspected cause of at least 2 cases with bacterial meningitis-like symptoms. Although the samples tested sterile at the time, an FDA employee told the Massachusetts pharmacy board that, "Sterilization techniques and aseptic practices continue to raise questions, despite no positive (nonsterile) results from latest samples," says the HELP report.

In a majority memorandum, the U.S. House of Representatives Committee on Energy and Commerce detailed the exceptionally long delay between the FDA's inspection of NECC in 2004 and its issuing of a warning letter on December 4, 2006. The letter detailed 4 "primary areas of NECC activity that constituted violations of the [Food, Drug, and Cosmetic Act] for which the agency would not exercise its enforcement discretion," according to the memo.

Mr. Cadden's Jan. 5, 2007 reply to the FDA opened by noting "the Warning Letter is based on an inspection of NECC that started on September 23, 2004, approximately twenty-eight months ago ... FDA has not contacted us since concluding the inspection. Some of the letter's assertions no longer apply to NECC's operations."

His letter claimed that NECC didn't "compound copies of FDA-approved commercially available drugs, introduce unapproved new drugs into interstate commerce ... process or repackage approved drugs" and didn't need FDA approval to dispense its compounded formulations, according to the memo. Further, Mr. Cadden wrote, "Nor are our compounded medications misbranded. NECC dispenses compounded medications upon the receipt of valid prescriptions."

The FDA failed to respond again until Oct. 31, 2008, with a letter that apologized for the correspondence delays and noted the agency was still concerned with NECC's production. According to the memo, the FDA wrote, "Your firm must promptly correct the violations noted in the December 4, 2006, Warning Letter, and establish procedures to assure (sic) that such violations do not occur. Its failure to do so may result in enforcement action including seizure of the firm's products and/or an injunction against the firm and its principals." The letter promised a future inspection, but this follow-up, 4 years after the inspection in question, "is the last documented correspondence between FDA and NECC until the recent outbreak."

The House Energy and Commerce Committee's Oversight and Investigations Subcommittee is now pressing the FDA to release more documentation regarding its interactions with NECC, according to a press release. As Rep. Cliff Stearns (R-Fla.), the subcommittee chair, wrote on the committee's blog, "The FDA's spotty history with the NECC dates back to 2002, when state and federal regulators initially found contaminated drugs. FDA Commissioner Hamburg [has] repeatedly asserted that the FDA lacked the necessary authority to do so. ... If the FDA had the authority to shut down the NECC in October of this year, why didn't it assert its authority in 2006?"

Stephanie Wasek

A New Way to Train Surgeons?

Perhaps teenagers who play video games for hours on end really shouldn't be outside playing or doing their homework. In a study performed at the University of Texas Medical Branch at Galveston, high school and college gamers outperformed medical residents on robotic surgery simulators, likely because repetitive joystick maneuvers match the movements needed to perform advanced robotic surgery.

In a head-to-head comparison, 9 high schoolers (who gamed on average 2 hours each day) and 9 college students (who gamed on average 4 hours each day) outperformed 11 UTMB residents (some of whom had already participated in actual cases) in how much tension they applied to instruments, hand-eye coordination and grasping steadiness when performing tasks such as suturing, passing needles through tissue or lifting instruments. (The residents, however, topped the students in tests of conventional laparoscopic surgery skills.)

Lead researcher Sam Kilic, MD, decided to test the impact video gaming had on robotic surgery proficiency after watching his teenage son - an avid gamer - test drive a simulator at a medical convention. "He was immediately at ease with the technology and the type of movements required to operate the robot," says the director of minimally invasive gynecology at UTMB.

Dr. Kilic says the growing number of tech-savvy and video-gaming medical students demands changes to conventional medical school curriculum. "We see students with enhanced visual-spatial experience and hand-eye coordination," he says. "We should rethink how best to teach this generation."

Daniel Cook

In Knee Replacement Surgery, Do the Eyes Have It?

The use of computer navigation technology in knee replacement surgery might not offer any advantages over traditional implantation methods, according to a South Korean study.

For the study, published in the November 21 issue of the Journal of Bone and Joint Surgery, researchers at Ewha Women's University School of Medicine in Seoul followed the cases of 520 osteoarthritis patients (452 women and 68 men) who underwent bilateral total knee arthroplasty. For each patient, 1 of the knees was replaced with computer assistance and the other conventionally.

Following up after 3 months, 1 year and annually for 10 to 12 years, the researchers found no statistically significant differences in post-op pain, alignment, mobility or durability between the 2 knees. Additionally, incision length and surgical blood loss were no different between them. They did, however, note that the computer-assisted knees saw longer operative times and tourniquet-use times.

"The effect of computer-navigated total knee arthroplasty compared with conventional total knee arthroplasty on long-term implant survival remains unproven," write the researchers.

David Bernard

InstaPoll: How Would You Rate the Teamwork in Your ORs?

Is it all-for-one and one-for-all in your operating room? Or are certain members of your surgical team only out for themselves? Rate the level of teamwork that you see in your ORs in this week's Outpatient Surgery Magazine InstaPoll.

Last week we asked who in your facility has the final authority to approve a patient for a case or cancel the case. The results, based on 719 responses, show that anesthesia (57%) most often has the final say, followed by the surgeon (21%), the medical director (17%, and keep in mind that most medical directors are anesthesia providers) and the administrator (5%).

Dan O'Connor

News & Notes
  • Body mass as SSI predictor The distribution of body mass is more predictive of SSIs following lumbar spine surgery than absolute BMI and deserves attention in pre-op evaluations, according to research published in the journal Spine. Among the nearly 300 patients studied, 24 suffered post-op infections. While BMI and diabetes weren't significant risk factors in the infections, obesity, skin-to-vertebra distance and thickness of the subcutaneous fat were.

  • Music to their ears Music therapy may reduce anxiety, pain, recovery time and use of sedatives, and may increase patient satisfaction, according to a study review published by the University of Kentucky in the Southern Medical Journal. The review examined the use of music pre-, intra- and post-operatively. Patients were less anxious before the procedure and recovered more quickly and satisfactorily afterward if exposed to music during and following the case. They also required fewer sedatives and reported better satisfaction with their medical experiences, according to the researchers. Lori Gooding, lead author of the review, suggests offering several playlists selected by experts, so you can ensure the music maximizes positive effects while accommodating different tastes.

  • CMS clarifies laser cataract payment The Centers for Medicare and Medicaid Services issued a statement last week clarifying that its coverage of laser-assisted cataract surgeries follows the same rules as that of conventional procedures, including 2 rulings involving patient payment for non-covered charges in the insertion of presbyopia- and astigmatism-correcting IOLs.