FDA's Ilisa Bernstein discusses current state of pharmacy affairs

May 12, 2008

Ilisa Bernsteain, FDA's director of pharmacy affairs talks to Drug Topics about a variety of pharmacy issues, including e-pedigree, REMS plans, risk management plans and other issus.

What are the latest developments about Medication Guides that pharmacists should know about?

FDA recognized pharmacists had concerns about Medication Guide distribution and availability. We had a meeting last year and we accepted comments to the docket. We have reviewed those comments and we have identified a three-pronged strategy to address the issues. We are going to look at what changes we need to do internally to make the process more efficient within FDA. We are going to determine what kinds of guidance are needed to outside stakeholders, such as pharmacists and manufacturers. There will also be an outreach component to make sure pharmacists know what their responsibilities are related to medication guides.

We are going to be putting in place different initiatives for post-market surveillance and pharmacovigilance that were part of the FDA Amendments Act and pharmacists will be right in the middle of it. The law was just passed and we have our implementation strategy and different bits and pieces will be coming out in the coming months.

In a March 27 notice, FDA asked the manufacturers of 25 high-risk drugs to develop REMS plans. How will this affect pharmacists?

The pharmacist will be a key player in carrying out REMS (risk evaluation and mitigation strategies) and will help mitigate the risks associated with these products that were identified. Some of these products have medication guides associated with them. That is a tool pharmacists can use in counseling the patient about the product and making sure they understand what's in the medication guide.

ASHP has asked FDA for a standardization of risk management plans. Can pharmacists expect to see more standardization going forward?

We had a public meeting to talk about risk management plans. We had a special panel that talked about the burdens that some of these programs place on pharmacists. We are looking at ways to increase the efficiencies of the programs, but in many cases the safety issue for how to manage the drugs are unique, so a cookie cutter standard process won't necessarily work. That said, we are still looking at ways that we can increase the efficiencies for pharmacists.

The California board has decided to delay the implementation of e-pedigree from 2009 to 2011. Do you think this will give time for the country to come up with uniform legislation, rather than a patchwork of laws by state?

I can't really comment on the extension. In FDAAA, FDA was given new authorities to develop standards for authentication, identification, tracking and tracing, and validation of Rx drugs as ways to secure the drug supply chain from counterfeits. We have a deadline of March 2010 to have identification standards in place for a unique number that can be placed on each package for tracking purposes. Whether Congress will come up with anything else to change that, I'm not sure.

Where do we stand on the suit compounding R.Ph.s filed against FDA. Is FDA appealing the judge's decision?

The appeal is still pending.

This FDA commissioner, unlike former commissioners, seems to be amenable to the idea of a third class of drugs. FDA held a hearing on this late last year. What will be the next step?

We are evaluating the comments now. Once we finish reviewing the comments, we'll know what our next steps are. We need to look at the legal and regulatory issues and the impact it has on public health and safety.

There are now more pharmacists working at FDA than ever before, Is the agency more receptive to the positions of pharmacists as a result?

I think there is really a good representation of pharmacists currently in FDA. With some of these new resources we probably will be getting more pharmacists. Maybe I'm biased as director of pharmacy affairs, but I think that the role of the pharmacist is taken into consideration as we put out policies and initiatives throughout the agency.