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The Following is the reply I received from Henry Malinowski who is director of the FDA division that approves all new drugs. I was impressed by the fact that his turnaround time in answering my e-mail was less than 3 or 4 working hours. He sounds like he means what he says and is concerned about a more rapid approval time for the new drug applications. If the 12 months adds sufficient safety and efficacy data to be useful then I support the position that they should take their time. Once a drug is released that has been proven safe in the 1-2000 people usually involved and say it has a rare side effect that is fatal in 1 in 4000, there may be a large number of seriously injured or dead patients before the side effect is linked to the drug. At that point we would all be yelling why doesn't the FDA protect us. I believe that there is a process where a physician can apply for an IND (Investigational New Drug) permit which allows him to use a drug premarketing. I will ask about that to Dr. Malinowski in my follow-up letter. It is a difficult question of what is being prudent and what is excessive. With a potentially life saving drug the answer is obvious but in the case of PD the answer is fuzzier. I sit here in my wheelchair and contemplate the question. Charlie Subject: > Re: Pramipexole > Date: > Thu, 08 May 1997 09:36:38 -0400 (EDT) > From: > Henry Malinowski 301-594-2567 FAX 301-480-3212 <[log in to unmask]> > To: > "Charles T. Meyer" <[log in to unmask]> > > > > > Dear Dr. Meyer, > > Thanks for yor message. I'll provide what information that I > can. > > >I write to you both as a physician and a 52 year old Parkinson's' > >Patient who is wheelchair dependent at this point. I am inquiring about > >the status of pramipexole in the approval process. Is there a question > >about the safety etc. of the drug or is there a bureaucratic log-jam > >that is preventing its approval along with several other similar drugs. > > I can assure you that there is no bureaucratic logjam at the FDA. All > original NDA submissions are precisely scheduled for either 6 month or > 12 month review, as a result of the User Fee Law which provides us with > additional personnel to review all NDA submissions in this time frame. > It will not be long before a decision is made at to the approvability of > pramipexole. I know that the availability of safe and effective drugs to > treat Parkinson's is very important to you and others needing such drugs > and I and others at the FDA feel a great responsibility to accomplish > our role in as short a time as possible. > > > > >Personally, my increased sensitivity to l-dopa induced dyskinesia > >coupled with increased freezing and a preexisting orthopedic problem has > >for the past 3 months essentially left me in a wheelchair. Because of > >the unpredictability of my symptoms and side effects I am unable to work > >as a psychiatrist. My neurologist has recently suggested pramipexole > >when it comes on the market. > > > >I participate in an internet Parkinson's group that has been growing > >increasingly angry as the slowness of the approval process deprives > >them(us) of a group of new PD drugs. While I certainly recognize the > >need for efficacy and safety studies, (I participated in one on > >entacapone) it certainly appears to lay persons as well as to at least > >this medical professional that the drug is being held up for other than > >scientific questions. > > I understand that it seems like too long a time but, with the number of > submissions that we receive, it's not possible to proceed any faster. > And we can only review what has been submitted by a sponsor, so most of > the time prior to approval is while the drug is under development by the > sponsor. > > > > >The anger grows at this point and it wouldn't surprise me if you start >> getting calls from Capitol Hill about the delays. If the delay has to >> do with lack of funding delaying the meeting of committees or that sort > >of thing or delays in filing by Upjohn then our anger may well be > >misplaced and therefore knowledge of the situation would be useful. I > >would very much appreciate understating what the hold-up is at this > >point and where to put the pressure- Otherwise I am afraid rightly or > >wrongly the blame will fall at the doorstep of the FDA given the > >agencies reputation for delays in drug approvals. > > As far as pramipexole, a decision will be forthcoming in a matter of 1 > or 2 months. Factors that can shorten the review time include > classification of a drug as "priority". This results in a 6 month or > less review time. Only breakthrough drugs fall into this category. > Certain classes of drugs have accelerated approval status, including > AIDs drugs and, now, Oncology drugs. I know of no problems scheduling > Advisory Committee meetings or other delays. I don't believe that we can > accomplish the review process in much less than the 6 month/12 months > prescribed limits, knowing the workload and staffing. This is much > improved from the past and I hope that these times seem > not too long to you. > > > >I hope you understand the urgency many of us feel and the approval > >process can be accelerated to pramipexole and the other PD drugs. > > I understand completely. I take my work here very seriously and we will > do our best to review all submissions as rapidly as possible, taking > care to always make the right decision. I wish you the best. > > Yours truly, > > Hank Malinowski > > Director, Division of Pharmaceutical Evaluation I > Office of Clinical Pharmacology and Biopharmaceutics > >