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FDA announced today that it is publishing a list of premarket approval applications (PMAs) that have been approved. The list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs. [FR Notice]

Heather Rosecrans, Director of 510(k) staff within FDA’s Office of Device Evaluation (ODE) has announced that she will retire on September 15, 2010. (FDANews)

While FDA does not plan to dramatically increase the requirements for clinical data in 510(k) submissions as part of its reforms to the 510(k) program, the Agency is proposing to split Class II devices into two subsets to clarify what types of products generally require clinical data to be included in the 510(k) submission. Additionally, FDA is considering revisions to its ‘de novo’ approval process and is discussing removing the requirement that companies must go through the full 510(k) process before submitting a de novo request. (Health News Daily)

Today, FDA announced the availability of a draft guidance entitled, “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.” The draft guidance stems from the Agency’s new authority to regulate the manufacture, marketing, and distribution of tobacco products granted by the Tobacco Control Act in June 2009. [FR Notice]

Some experts believe that FDA’s dietary supplement good manufacturing practices (GMPs) are creating costs that could drive more firms to file new drug applications (NDAs) for natural products. The more stringent manufacturing requirements imposed to help assure that safe nutritionals reach the market satisfy some work required for an NDA, and might encourage manufactures to continue down that path in order to be able to make stronger claims about the product in question. (Health News Daily)

FDA announced today the availability of a draft guidance for industry, entitled “Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment,” intended to assist clinical trial sponsors and investigators in the development of antimicrobial drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI), impetigo, and minor cutaneous abscesses. This guidance for clinical trial sponsors and investigators also addresses the clinical development of new drugs to treat drug-resistant bacterial pathogens implicated in ABSSSI, such as methicillin-resistant Staphylococcus aureus. [Draft Guidance] [FR Notice]

Despite the refusal of a federal judge to issue a preliminary injunction to block Sandoz and Momenta Pharmaceutical from proceeding with sales of their generic Lovenox bloodthinner, which was recently approved by the FDA, sanofi-aventis, the manufacturer to Lovenox, intends to proceed with their suit against FDA approval of the generics. Sanofi alleges that FDA’s approval of the generic blood clot preventer in July “was arbitrary and capricious,” and that the Agency failed to follow its own procedures or ensure the generic drug had the same active ingredient as Lovenox – a complex injectable drug that Sanofi argues is hard to replicate accurately. (Reuters)

FDA is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following four Class III preamendments devices: ventricular bypass (assist) device, pacemaker repair or replacement material, female condom, and transilluminator for breast evaluation. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute’s approval requirements and the benefits to the public from the use of the devices. [FR Notice]

According to Bowman Cox, managing editor of the Gold Sheet, drug recalls reached a record high of 1,742 in 2009, and are on track to reach over 600 this year, given the 296 so far this year. Analysts believe that this rise in recalls results from four primary factors: drug repackaging, generic drug design, manufacturing lapses, and increased FDA scrutiny of manufacturing facilities. (Health Reform Watch)

The Joint Meeting of FDA’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee convened on Friday to discuss Jazz Pharmaceuticals’ Rekinla (sodium oxybate) to treat fibromyalgia and voted 20-2 that the benefits do not outweigh the associated risks. Because the Sponsor currently markets the same drug, sodium oxybate, under the brand name Xyrem, for the indication of cataplexy and excessive daytime sleepiness in narcoleptic patients, Panel members expressed concern regarding potential medical errors arising from the company marketing the same drug under two brand names and stated that the company should bolster its Risk Evaluation and Mitigation Strategy (REMS). (The Pink Sheet Daily)

Yesterday, FDA’s Anesthetic and Life Support Drugs Advisory Committee voted 8-5, with one abstention, that Cymbalta was effective for the treatment of chronic lower back pain (CLBP), but 9-4, with one abstention, that the drug was not effective for the treatment of osteoarthritis; reported by a statement from Bob Rappaport, Director of FDA’s Division of Anesthesia and Analgesia Products, the CLBP and osteoarthritis studies did not meet the standard for a general chronic pain indication. The Panel also voted 9-4, with one abstention, that the drug’s safety profile and risk-benefit ratio warranted expansion of the indication and 8-6 in favor of approving the expanded pain indication to a broader population. (The Pink Sheet Daily)

Tomorrow, FDA will convene a Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to consider Jazz Pharmaceuticals’ new drug application for Rekinla (sodium oxybate) to treat fibromyalgia. Because the Sponsor currently markets the same drug, sodium oxybate, under the brand name Xyrem, for the indication of cataplexy and excessive daytime sleepiness in narcoleptic patients, the FDA review team has expressed concern regarding the Sponsor’s proposal to use two separate Risk Evaluation and Mitigation Strategies (REMS) to prevent medication errors for the same active ingredient marketed under two brand names, as the indication-based REMS could become confusing to pharmacies, patients, and prescribers. (The Pink Sheet Daily)

Tomorrow, FDA’s Anesthetic and Life Support Drugs Advisory Committee will convene to consider Eli Lilly’s new drug application for Cymbalta (duloxetine) for the proposed indication of chronic pain. According to the meeting briefing materials, the FDA review team expressed concern that the expanded indication could create safety issues, including exposing a larger population to a risk of hepatoxicity. (The Pink Sheet Daily)

In an effort to bolster manufacturing site monitoring and reduce unnecessary duplication, FDA and the European Medicines Agency (EMA) are seeking candidate companies for a joint good manufacturing practices (GMP) inspection pilot program. Drug manufacturers that have submitted premarket applications in parallel to both FDA and the EMA can request to participate in the pilot program for a joint preapproval inspection. (World Pharma News)

On Friday, FDA announced the approval of ella™ (ulipristal acetate) tablets for emergency contraception, to prevent pregnancy for up to five days. The drug was approved following a favorable FDA Advisory Committee meeting in June 2010, which reviewed safety and efficacy data from two Phase III clinical trials. (FDA Press Release)

In response to FDA’s draft infusion pump guidance, several medical device manufacturers are requesting that the Agency delay implementation of the guidance, to allow more time for clarification of its provisions. One manufacturer, Baxter, suggests a delay of between 12 to 18 months to assure all confusion is resolved before final implementation. (FDANews)

Yesterday, GlaxoSmithKline and Valeant Pharmaceuticals’ antiepileptic drug Potiga (ezogabine) received a positive review from FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, due largely in part to GlaxoSmithKline’s risk management plan, which alleviate many potential concerns regarding the drug’s side effects. The Panelists voted 13-0 that the drug is effective, 11-0 with two abstentions that the drug’s urinary retention problem can be mitigated by patient monitoring, and 13-0 that there is no need to monitor for urinary tract infections and urolithiasis. (The Pink Sheet Daily)

Today, FDA and the Centers for Medicare and Medicaid Services (CMS), announced a memorandum of understanding (MOU). The MOU seeks to promote collaboration and enhance efficiency by providing for the sharing of information and expertise between the Federal partners. [FR Notice]

According to an FDA task force report, released in conjunction with CDRH’s proposed 510(k) premarket review reforms, the device industry has taken too broad an interpretation of the “least burdensome” statutory provisions, hindering reviewers’ ability to access information needed for clearance or approval of new products. FDA’s report attempts to address industry criticism that the Agency has been unpredictable in its regulatory demands during premarket reviews. (The Gray Sheet)

A week after the first two Center for Devices and Radiological health (CDRH) Device Panel Meetings in which Panelists voted on scientific questions of safety and effectiveness as well as risk versus benefit, instead of on the approvability of devices of the recommended conditions of approval, an Agency representative stated that FDA “will implement slight modifications as needed.” One potential change would be to “allow a greater opportunity for the panel members to discuss the reasons for their votes.” (The Gray Sheet)

FDA announced today the availability of a guidance for industry, entitled “Drug Substance Chemistry, Manufacturing, and Controls Information.” The guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug substances that should be submitted to support original new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs). [Guidance] [FR Notice]

FDA’s Center for Devices and Radiological Health (CDRH) has hired Dr. William Maisel, an electrophysiologist at Harvard/Beth Israel Deaconess, and founding Director of the Medical Device Safety Institute, as well as a longtime advisor to FDA.  According to CDRH Director Dr. Jeffrey Shuren, Dr. Maisel has been brought aboard to head a new “science council,” which will ensure the consistency and integrity of science-based decisions at CDRH.  (The Gray Sheet)

CDRH released today the results of its two comprehensive preliminary internal evaluations regarding the 510(k) premarket review process, and the role of science in how CDRH makes regulatory decisions. According to a forward by CDRH Director Dr. Jeffrey Shuren, the Center’s main goals are to foster medical device innovation, to bolster regulatory predictability, and to enhance patient safety. One major change under consideration is the establishment of a “Class IIb” subset, for which devices would require clinical or manufacturing information as support for a substantial equivalence claim. [Reports]