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November 15, 2012
But the industry has now evolved so that you have some large compounding pharmacies that are mass producing medications. because they are compounding pharmacies they dont face the same federal regulation and oversight as drug manufacturers. one of the things this committee is exploring is whether that needs to change, martha. martha: one of the pharmacy owners apparently was called to testify. what do the senators hone they are going to learn from him? >> yeah, necc coowner barry cadden was supp...
November 14, 2012
Of attention to the duties cost my husband his life. >> as a compounding pharmacy, any cc does not same federal oversight as the drug manufacturers. members of congress are trying to determine whether regulators dropped the ball or whether their hands were tied by what the fda commissioner described as a crazy quilt of legal authority. >> what we do know that s that stronger clearer authority would enable more effective regulation of the drug compounding industry. especially when it has been evo...
November 14, 2012
Husband his live. >> she testified to put a human face on the case numbers we keep seeing in this outbreak, traced to the company, a bipartisan effort to determine whether the outbreak could have been prevented. we will see a debate over whether it is an isolated case best handled by the courts or whether it is a symptom of a need to beef up the f.d.a.s ability to regulate compounding pharmacies which currently are mostly regulated by individual states. >>shepard: thank you, jonathan. and before...
October 23, 2012
Also its three principle pharmacists, shep? >> shepard: incredible outbreak and deadly. what are they doing to keep this from happening again? >> at the state level, massachusetts has announced increased regulation of these compounding pharmacies. there are 25 of them in that state. the increased regulation will include surprise inspections. in fact, the first such inspection was carried out earlier today. a supreme court ruling found that past efforts by the fda to regulate these pharmacies at ...
October 22, 2012
Tragic, they are a relatively small number compared to the millions of doses of medications that americans are taking from the nations drug manufacturers and compounding pharmacies. he says in general the process of making the drugs is very safe but that doesnt mean we cant make it safer. >>shepard: in the early going of this outbreak those in charge said if you dont have symptoms you do not need treatment s there any talk of treating people preemptively? >>jonathan: the discussions are ongoing ...
October 13, 2012
In your spine or even in your arm from one of these compounding pharmacies check with your doctor to see. >> clayton it is only one compounding pharmacy. >> right that one up in massachusetts. >> the one in massachusetts. this is a reminder for us. if you are getting a shot, there is always a risk of introducing foreign body, infection. people should realize i do need this shot? i dont want to scare anyone out there. i think the fact that its not contagious calm. this is a wakeup call. did you n...
October 12, 2012
Describes as emotional distress and medical expenses and bodily injuries for this woman and also for the other patients in minnesota who received the possibly tainted injections. trace? >>trace: we have mentioned the compounding pharmacies mix together their own drugs. have we heard anything from the pharmacy? >>guest: not much. we know theyhired a lawyer. he is a prominent boston criminal defense lawyer who specializes in health care law. this initial civil suit filed in federal court is on beh...
October 11, 2012
>> you know its interesting, unlike drug manufacturers, which face stiff regulation by the fda its very different for these compounding pharmacies, these are pharmacies that take in drugs from these outside manufacturers, and then either combine them or alter them in a way to distribute to patients who for some reason cant take the drugs in their original form. well, the fda has tried to regulate these compounding pharmacies, but in 2002 the supreme court overturned a law that would have given t...
October 11, 2012
Treatment represents idahos first case associated with the fungal meningitis outbreak. officials say a total of 39 people in that state received the potentially tainted injection but nationwider diseal estimates up to 14,000 people were potentially exposed to the tainted injection. the centers for disease control says roughly 90 percent of those at-risk patients have already been contacted. >>shepard: a lot people have never heard of the pharmacies that put medicines together. they avoid the lar...
October 11, 2012
>> its a state rule. in massachusetts, compounding pharmacies can only make individual medications for individual prescriptions. in other words, if a patient needs a pill convert to do a liquid, for example, this doctor writes a prescription, the pharmacy fills it. but the center was operating more like a drug manufacturer, making large batches of this injectable back pain steroid and then shipping them to clinics around the country. tonight were learning the massachusetts attorney generals offi...