Attorney wary FDA changes will

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Business Journal: How do you expect the FDA’s approachy to regulation of medical devices to change underMargaret Hamburg? Hamburg has announced that she will stress the publif safety aspect of the FDA’s Ten years ago, people were concernede about getting medical devices to marketg and providing things to patients. Every persom working within the agency will now feel empowered to stop the marchhof technology. If there’s anything they see wherse there may be a risk the balancing is going to be I feel the emphasis will shift so technologg is viewed as the enemy rather thanthe solution. Business The 510(k) clearance process has come under intense scrutiny recently.
FDA scientists in January wrotd a letter to President Obama saying the approval procesxs for medicaldevices ‘has been corrupted and The FDA also has been asking for more data beforr approving devices. Do you expect to see reform of the process in thecoming years? Klepinski: The changee has been occurring for years. Therde has been an increasing lust for data on the part ofthe FDA. When you ask they will respondthat it’s because of the increasiny complexity of technology. I believe that statement is but also, just based on the pendulum swinginfgin Washington, and a sort of general conservative approach, they are afraid to make decisionsz without more and more data.
With the combination of that shifr in technology anddemeanorf … it’s worse for devicew companies getting products out, and worses for patients looking for solutions. Businesds Journal: The FDA in June created a ‘transparency task to make consumers more aware of the process it uses to approvde drugs andmedical devices. It’z even started a ‘transparency Some companies have expressed concerns that this process will lead to more clinica data being released tothe public. How do you thinkk this transparency initiative is likel to affectthe med-tech industry ? Klepinski: No comment.
Business Journal: The FDA has releasedc draft guidelines that describehow med-tech and drug companiesz should craft advertisements and marketing materials to avoid runnint afoul of regulations. These are nonbinding, for now. Med-techh companies don’t advertise to consumers in the same way drugcompaniea do; however, do you see anything in theswe guidelines that are likeluy to have a big impact on medical-device makers?? Klepinski: Any movement by the FDA to providw more guidance on advertising and promotiobn is welcome, but I don’t believw it’s dramatic.
Business Journal: Medical-device makers have been criticizee for dragging their heels when it comesto post-marketg studies. Do you see the FDA puttingh pressure on companies tocomplete post-market studiesa more quickly? Klepinski: It’s a long-time trene that’s not going away. I thinjk there was foot-dragging a decade ago, but that has dramaticall y shifted. In general, what the public has to understand is that when Congressdrafte legislation, it was not designes for continuous control of the products. The PMA (pre-market approval) was a one-timse event, and only in an extremwe case could itbe revoked.
There’s been pokingv at the edges of ways toimprovse that, without structural changes. It’s going to be here-and-there attempts.