Members of that FDA Advisory Panel that met on 7/12/12 and voted against recommending approval of the painkiller Zohydro ER won't be the same people voting on the FDA March 1 PDUFA. The simple fact of the matter is that the FDA currently has no regulations that mandate that manufacturers make pain medication tamper resistant.
After reading below you will understand why Zohydro actually has a chance at getting approval from the FDA on 3/1/13.
The real reason for the big tamper resist argument going on right now is because the patents for all the major drug manufacturers have run out on the most popular opiate pain killers (Oxycontin, Opana, and Exaldo). They have all made a new tamper resistant formula and want the old formulas banned so they can continue to control the market with their new tamper resistant patents. That will save them from losing market share to all the companies that will be able to start selling the generic forms of the non tamper resistant formulations that have been on the market for years.
The reality is the new formulations made to be tamper resistant are no good. They make patients sick, vomit, choke, and gag, and worse their efficacy is seriously diminished. You will hear the word placebo floated around quite often by legitimate patients. Plenty of legitimate patient forums out there to confirm that fact. My brother has been on Oxycontin for years and when he got the new formula last year they were like a placebo to him. He has since discontinued Oxy and only takes regular instant release hydrocodone.
Now here is the rub…
Last year the patent ran out on Opana which is similar to Oxycontin allowing other manufacturers to make generic versions. The pharmaceutical company that makes Opana had already switched to a tamper resistant formulation and ended up suing the FDA to stop the non tamper generic formula from being sold using the argument that their old version was dangerous. I can just see the Judge thinking that if it was dangerous then why were they selling it themselves for so many years. The Federal Judge hearing the case threw it out in Dec 2012 and allowed the generic drug manufacturer to start selling the generic version just this past month in January. The Judge threw out the case primarily because the FDA had made no such ruling to stop non tamper resistant formulas from being sold and they still have not changed the regulations.
Interestingly that court case was ruled on after the Advisory Panel advised against approval of Zohydro. It occurs to me if the FDA refuses to approve zohydro then Zogenix might actually have a legitimate case against the FDA since the ruling in Federal Court over generic Opana on the issue of Tamper Resist formulations has set a precedent.
Again he FDA doesn't have to follow the recommendations of its Advisory panels, and often times it goes its own way.
Then there is Zogenix's voluntary REMS placing zohydro on the DEA Schedule II classification that puts it on par with other opiates like Opana and oxycontin meaning it won't be easily obtainable and patient prescriptions are meticulously reported to the DEA and they use that information to investigate individuals with prescriptions. That makes it kind of easy for them to home in on who is illegally selling them.
Considering the safety profile of the drug and the risk evaluation and mitigation strategy submitted by Zogenix with its application, it seems there's at least a cogent argument to be made in the drug's favor of ultimately getting approved.
Zogenix has already met, or exceeded the current FDA regulations and requirements for zohydro in the REMS submitted Dec 7th that was given the thumbs down by the ADCOM which is why Dr. Bob Rappaport, director of anesthesia, analgesia and addiction products at the FDA, admonished the panelists to distinguish between zohydro and other opiates lest they be seen as "punishing this company and this drug because of the sins of other companies their product." He went on to say that "From a regulatory standpoint, that's not really something we (The FDA) can do."
People are buying into the propaganda regarding the abuse issue being used to hide the real motive behind this controversy. The real motive of course boils down to patents and profits. The needs of legitimate patients are being completely ignored.
Don't let the big pharmaceutical corporations fool you. They are behind the push for tamper resist formula's in order to stop the other drug manufacturers from selling generic versions of the top selling pain medications they have held a monopoly on for years. The big pharmaceutical companies are lobbying certain members of Congress who are working in collusion with the DEA to use the abuse issue to get the FDA to ban all non tamper resist formula's only because the patents have run out on the old formula's that have been around for years. If they get their way legitimate patients will suffer because the new formula's are no good and to top it all off these greedy politically connected phamaceutical corporations will be able to continue to charge outrageous prices for them because they will have the exclusive patents and monopoly on the new tamper resist formula's. How convenient that the formulas these companies have been making billions of dollars off of for years have suddenly become so dangerous they have just now as their patents run out decide they should go to Federal Court in order to try and have their own drugs banned.
Lets not forget that the taxpayer ends up paying for most of the cost of these new tamper resistant brand name pain medications since most people only pay a small co-pay and Medicare pays the rest by reimbursing the healthcare providers and pharmacies. Of course the generic form of these medications without the tamper resist ingredients would only cost a fraction of what is currently being charged. Were talking billions of dollars in savings toithe taxpayer. Lest we forget even if they do ban the old formulas in the United States they are being manufactured in Canada which is where drug abusers will still be able to get all they want. So you see this whole tamper resist issue is nothing but a smoke screen to manipulate public opinion with the false premise that it will prevent drug abuse in order for a small handful of Pharmaceutical companies to maintain their market share and be able to rake in billions of taxpayer dollars.
It is so disgustingly transparent what is going on its ridiculous. Its all about the Patents and the Profits and has nothing to do with abuse.
It is worth repeating that the new tamper resist formula's don't work very well and are making legitimate patients sick. Legitimate patients are being made to suffer so a few politically powerful drug companies can keep their monopoly.
Senator Schumer is the heavy weight in Congress who is leading the charge by misrepresenting the abuse issue in order to protect the profits of his Big Pharma donors.
One last thing I forgot to mention. The articles being weitten in the media give no mention of the fact that patients who now have to take between 6-12 pills a day that are full of liver damaging acetaminophen that add up to well over the maximum 4,000 mg safe amount would be able to take just 1, or 2 pills a day with zero acetaminophen.
The FDA has been after drug manufacturers for years to come up with a pain killer that does not have acetaminophen. Zogenix finally delivers the product they wanted in a form that would help millions of people and now they are being demonized with lies and exaggerations such as the outrageous notion that zohydro is x10 more powerful than vicodin. Never mind the fact that they are using the absolute smallest dosage of a hydrocodone pill available against the highest dosage of zohydro available to make the misleading calculation.
That is what I call complete and utter fabrication for the sole purpose of propaganda. It is a "no brainier" why the major politically connected drug manufacturers want zohydro shot down. It is a far superior medication than the junk they are pedaling to doctors to push on sick people who have no voice in the debate.