Washington, DC (APE) – The FDA, as a result of an ongoing feud with its advisory panel, announced this weekend that from this point on, all pharmaceuticals with no exclusions will have black boxes. This action comes on the heels of the advisory panel’s Thursday recommendation in a 12 to 1 vote to not approve Cephalon Inc.’s Sparlon for the treatment of ADHD. A recent suggestion for blackbox warnings for all medicines used in the treatment of ADHD by the advisory panel, was later overruled by the FDA.
Cephalon’s shares plunged almost 13% as a result at the close of trading Friday. Georgia-Pacific’s shares rose almost 20% as a result of the same news.
A black box “warning” is the strongest action that the FDA routinely takes short of banning a drug from sale. The new blackbox packaging mandate issued this weekend will be used as a step prior to an official blackbox warning. The pharmaceutical industry will be given approximately 3 months to comply.
A spokesperson for the Bush administration controlled FDA stated, “We simply have no choice in the matter. If the average physician in his or her office cannot take the time to simply go over in depth with the patient the entire package insert on a typical medication regarding all side effects and dangerous or lethal outcomes no matter how remotely possible, then we must act. For God’s sake, they weren’t even telling women that the use of RU-486 is routinely killing embryos.”
The spokesperson went on to say that the universal blackbox was not expected to go over well with the pharmaceutical industry, but that a number of options were available for companies seeking redress. Companies would be allowed to keep their same logos and colors but the overall box must be black. Companies wishing to make major tax-free donations to consumer advocate groups such as “National Right to Life” would be taken into consideration to be allowed to keep their original packaging.
Overall, the response from the pharmaceutical industry has been mixed at this early juncture. Many companies insist that they will fight what they consider an unfair and frivolous ruling through legal and political means. Other companies have taken the mandate in stride and already begun marketing campaigns. A consortium of companies which have elected not to fight the blackbox mandate have already proposed a universal slogan for the industry: “A new and improved blackbox, but the same proven medicine and side effects you’ve come to know and to trust.”