In today's roundup...
FDA Panel Begins Acetaminophen Assessment: McNeil Consumer Healthcare says label changes and innovative package designs will more effectively reduce the risk of liver damage from acetaminophen overdosing than FDA's proposal to remove certain forms of the drug from the market.
Watson Hints At August Delivery For Plan B Generic: A Watson Pharmaceuticals spokeswoman confirms that the company is pursuing approval of a nonprescription levonorgestrel equivalent, aiming to make it available upon the expiration of Teva's market exclusivity August 24. The only wild card remaining is the speed of FDA's approval process, she says.
NSAID Labeling Rule Cost To Industry Explodes: FDA corrects its April 29 final rule requiring organ-specific label warnings for OTC products containing acetaminophen or nonsteroidal anti-inflammatory drugs. The revised final rule, according to an advance June 30 Federal Register notice, bumps up first-year, one-time, industry-wide re-labeling costs from $32.6 million to $62.7 million.
CSPI Puts FDA In The Loop On Bayer One A Day Multivitamins: The Center for Science in the Public Interest says it is not enough for Bayer, without FDA intervention, to remove qualified health claims linking selenium to prostate cancer prevention from its One A Day Men's multivitamins labeling and marketing.
Whey Protein Supplier Recalling Ingredients With Salmonella Concerns: FDA announces the latest recall of salmonella-contaminated products, this time from the Plainview Milk Products Cooperative. Two years worth of ingredients, including whey protein and fruit stabilizers, are being recalled, the Plainview, Minn.-based company says.
FDA Panel Begins Acetaminophen Assessment
FDA's Drug Safety and Risk Management, Nonprescription Drugs and Anesthetic and Life Support Drugs advisory committees are charged with evaluating a number of risk-mitigation options FDA developed through an internal working group – several of which would make a big impact on McNeil's Tylenol brand and other OTC products containing acetaminophen – by eliminating certain doses or deliveries from the market.
FDA's proposed options include reducing the maximum dose of OTC acetaminophen, switching the currently maximum dose to prescription-only, limiting pack sizes, eliminating combination products and allowing only a single liquid concentration, as "The Tan Sheet" reported here.
McNeil argued that some of FDA's options do not address the root cause of the risk and would potentially create more harm than good. So while the firm supports increased public education efforts and greater clarity in labeling, it said reducing the single adult maximum dose from 1,000 mg to 650 mg and the daily dose from 4 grams to 2,600 mg to 3,250 mg, as FDA proposes, would have the unintended consequence of driving increased use of nonsteroidal anti-inflammatory drugs and with it, increased risks of gastrointestinal bleeding and renal failure.
Instead, McNeil proposes amending dosing instructions to prompt more consumers toward the lowest effective doses. In order to "decrease overall acetaminophen exposure," labels would direct adults to take one caplet every four to six hours, and a second only if their pain or fever does not respond, the firm says. Current directions say to take two tablets.
Instead of limiting pediatric liquid products to a single concentration, McNeil proposes the products be sold with flow restrictor packaging that can be used only with the included dosing syringe, and creating packaging that more clearly distinguishes between concentrations for infants and older children.
During the open public hearing, Wyeth Consumer Healthcare executive Paul DesJardins disputed McNeil's characterization of risks related to switching to NSAIDs. He said McNeil inappropriately relied on prescription drug data and the real risks "do not fit the dire predictions" made by McNeil.
DesJardins, the firm's senior VP of global clinical and medical affairs, also offered FDA an alternative approach to removing combination products from the OTC market: regulating them under the new drug application system instead of the monograph system, thus providing closer oversight of potential risks.
Watson Hints At August Delivery For Plan B Generic
A Watson Pharmaceuticals spokeswoman confirms that the company is pursuing approval of a nonprescription levonorgestrel equivalent, aiming to make it available upon the expiration of Teva's market exclusivity August 24. The only wild card remaining is the speed of FDA's approval process, she says.
This week's issue of "The Tan Sheet" reports that a generic version of Teva's Plan B emergency contraceptive is a strong likelihood in the near future, since Watson announced the approval of Next Choice for Rx sale.
Watson says it will initially accept the same pharmacy sales and age restrictions as the innovator product, but it will leave the door open for more universal sales status down the road.
Scott Gottlieb, a resident fellow at the American Enterprise Institute for Public Policy Research, writes in an e-mail that the agency will likely maintain the same sales restrictions on branded and generic Plan B, but could change both if an applicant makes the case.
Gottlieb testified to the House Energy and Commerce Committee June 24 that decisions to regulate access to medical care should be "based on sound science and a fair and transparent process" – qualities that many say did not characterize FDA's original decision to make Plan B available to 18-year-olds without a prescription, as Over the Counter Today blogged here.
NSAID Labeling Rule Cost To Industry Explodes
FDA corrects its April 29 final rule requiring organ-specific label warnings for OTC products containing acetaminophen or nonsteroidal anti-inflammatory drugs. The revised final rule, according to an advance June 30 Federal Register notice, bumps up first-year, one-time, industry-wide relabeling costs from $32.6 million to $62.7 million.
Where is this inflation coming from? The agency says its previous estimate of the products affected by the final rule was off-base. In April, FDA determined that 53 percent of the affected SKUs were NSAIDs. Now it says the proportion is actually 66 percent. The significance is that extant OTC blister packs for NSAIDs are not large enough to accommodate the revised labeling, so both inner container and outer carton will have to be expanded. Packaging for OTC acetaminophen will not need to change, FDA says.
The number of total SKUs affected by the final rule is still projected as 18,000 by FDA, while industry consultant Eastern Research Group says it could be as high as 25,000. Firms have until April 29, 2010 to make the label changes.
"The Tan Sheet" detailed what the rule will mean for industry and consumers here.
CSPI Puts FDA In The Loop On Bayer One A Day Multivitamins
Without agency intervention, Bayer agreed to remove qualified health claims linking selenium to prostate cancer prevention from its One A Day Men's multivitamins labeling and marketing (as "The Tan Sheet" reports here).
But that's not enough for the Center for Science in the Public Interest. In a June 29 letter to Barbara Schneeman, head of FDA's Center for Food Safety and Applied Nutrition, CSPI requests the agency "seize existing stockpiles of the Bayer products containing the cancer prevention claim." The center is concerned that Bayer might continue using an unsupported structure/function claim, namely that selenium "supports prostate health."
Stephen Gardner, director of litigation for CSPI, says in an e-mail that Bayer still has until July 18 to respond to the center's initial request that the selenium claims be halted, before CSPI initiates possible legal action. "We would much prefer to resolve the issue without a lawsuit," Gardner says.
Whey Protein Supplier Recalling Ingredients With Salmonella Concerns
FDA announces the latest recall of salmonella-contaminated products, this time from the Plainview Milk Products Cooperative.Two years worth of ingredients, including whey protein and fruit stabilizers, are being recalled, the Plainview, Minn.-based company says.
Plainview notes in a June 29 release that USDA discovered salmonella in its products that had already left the facility and been mixed with other ingredients. However, FDA did find some salmonella on manufacturing equipment in the Plainview facility, and the firm is now disassembling all equipment for cleaning. No illnesses have been reported linked to Plainview ingredients.
The company's Web site provides a product profile for dairy whey protein, the most recent one dated Feb. 23, that says a "typical analysis" was negative for salmonella.
The Web site's certifications page also indicates the ingredient producer received a "superior rating" from auditing firm AIB International and participated in an AIB food safety program May 2008. A spokeswoman said AIB does not divulge which facilities it audits. A spokesman for Plainview also did respond to questions regarding which manufacturers purchase ingredients from the cooperative.
FDA's efforts to get ahead of food-borne outbreaks appear to be working. Since the nationwide nightmare of salmonella in peanut butter, the agency has handled contaminated pistachios, cookie dough and now milk products before full-blown crises could emerge. "The Tan Sheet" continues to follow the food safety legislation moving through Congress, which could give FDA even more expansive authority to clamp down on food facilities. Read our most recent report here.
- Dan Schiff (d.schiff@elsevier.com) and Christopher Walker (c.walker@elsevier.com)
(For more news from "The Tan Sheet" click here for a free trial or kick off your subscription today.)
