BIO CEO Greenwood In A Conversation With “The Pink Sheet”

Biotechnology Industry Organization President and CEO Jim Greenwood reflects on the trade group's legislative priorities in 2007 as the new Democratic-controlled Congress gets to work. Greenwood joined BIO in January 2005 after 12 years in Congress as a Republican Representative from the 8 district of Pennsylvania. In Congress, he served as chairman of the Energy and Commerce Committees Subcommittee on Oversight and Investigations, where he led a review of drug reimbursement issues and contributed to the passage of the Medicare Modernization Act of 2003.

The following is excerpted from a Jan. 5 interview.

"The Pink Sheet": What are legislative priorities for BIO in 2007?

Jim Greenwood: Well of course the most important thing for us in 2007 is getting [the Prescription Drug User Fee Act] PDUFA reauthorized...We'd like to get it through cleanly without extraneous amendments but we know that will be a challenge. Whether those amendments have to do with drug safety or follow-on [biologics] or for all we know, tobacco, I think that will be a struggle to get that done in a timely fashion and get it done without amendments that will be counter-productive in terms of getting drugs to patients.

Data Mining To Monitor Drug Safety

"The Pink Sheet": What are your expectations for movement on the drug safety legislation sponsored by Sens. Michael Enzi (R-Wyo.) and Edward Kennedy (D-Mass.)? [Editor's Note: Kennedy and Enzi are likely to reintroduce provisions of their drug safety bill, S 3807 ( ¹ "The Pink Sheet" Nov. 20, 2006 , p. 6).]

Greenwood: We would anticipate that Sen. Kennedy, in his new role [as chairman of the Senate Health, Education, Labor and Pensions Committee] would want to be incorporating some of the provisions [into PDUFA reauthorization legislation]. And so there will be a lot to debate there.

Fundamentally we think the best way to provide additional safety to consumers is through one of the new and increasingly sophisticated mechanisms by which one can correlate prescribing data with treatment data and that's a data mining process that CMS is now involved in with Part D. We would like to advocate a major move in that direction, which benefits everyone.

It's good for consumers, it's a continuing advancement of electronic health records and it's good for the companies because it gives them one of the best ways to get early signals about adverse effects. I think that's a lot better than mechanisms that would bog down the approval process and cause drugs to be removed from the market wholesale when in fact there may be a very small subsets of the population that are experiencing adverse effects.

"The Pink Sheet": How would such a data mining initiative be established?

Greenwood: I think it's a big effort. There are a variety of ways it could be done. It's expensive, so I think if Congress is serious about this it should put some money on the table. But starting with the Medicare data as a large databank, [it could be established] by creating algorithms that correlate treatment data with prescribing data, whether this is done by a third-party private entity, or whether it's done by CMS, or whether it's done by FDA.

Instead of relying on anecdotal, voluntary reports by doctors, you would have a consistent creation of data that says, for instance, here is a product that's been prescribed to four million people in the past three months...We see that 320 of them have been treated for a particular liver function. Let's look at that data and look at other data that describes the patients. Are these patients taking other medications, so we're seeing that kind of effect? Are they of a certain ethnic composition, are they of a certain age composition, gender?

Of course there are a lot of tricky parts to this. Interpreting the data is tricky....And then of course you have to figure out how to this so that it just doesn't become a bone to the trial lawyers to every time there's some signal out there to start filing suit.

"The Pink Sheet": How might Congress proceed on this initiative?

Greenwood: Congress, if it wanted to, in the boldest way could create the data collection system. It could fund it, it could house it somewhere - probably at the FDA. It could pay for the establishment of it, the creation of the hardware and software to do all of this, and then construct the privacy mechanisms that are necessary and the protections against frivolous suits that could come from misinterpreting the data. So it's a significant undertaking but we're seeing this inevitably happening in the private sector and I think it's clearly the wave of the future. It's what the world needs and if key members of Congress got excited about it, it could really make a contribution to health care in the country.

"The Pink Sheet": Do you see any interest among key members in doing something like this?

Greenwood: It's a fairly arcane subject and so I haven't had the opportunity to talk to members about it. We've actually been sort of talking internally about whether we could build a coalition of patient groups and drug companies and consumer groups who would want to really create some momentum for something like this....At our last board meeting in San Francisco in December, [former CMS Administrator] Mark McClellan at our request made a presentation on this very subject.

Gearing Up For Negotiations On Generic Biologics Bill

"The Pink Sheet": What is BIO's approach to addressing the legislation sponsored by Rep.Waxman to establish a regulatory pathway for approving follow-on biologics?

Greenwood: I have been spending some time on the Hill, as has our staff, and we've been giving "Biologics 101" briefings to key members of Congress, particularly on the Health Subcommittee of the Energy and Commerce Committee...and explaining that it is impossible to fully characterize most large molecules and we offer the argument that in order to ensure safety and efficacy, if there is any legislation, the follow-on manufacturer would need to bring sufficient clinical data to establish safety and efficacy....

Of course, we also argue that the trade secrets involved in the manufacturing process of the originator need to remain so and shouldn't be provided by the FDA to would-be follow-on manufacturers.

"The Pink Sheet": How would you define what constitutes sufficient clinical data for such approvals?

Greenwood: BIO's position is a full set of clinical data. I think that's subject to interpretation and I think it's pretty clear that ultimately the FDA is going to have to have the authority to determine, based on a number of factors including how clearly one can or cannot characterize a molecule, how much data would be required. I think it's probably difficult to legislate that down to the final detail.

There are other issues with regard to the legislation that Waxman is introducing....There are other protections that are given to originators in terms of exclusivity [in existing generic drug law] that are not found in this new legislation, so obviously we would be arguing for some of those trade-offs.

I've known Henry Waxman for a long time and I think his modus operandi is to introduce the bill sort of as far to one side as possible, and I think he's succeeded doing that here and I think he knows as well as we do that the bill needs to move considerably towards the center before it's accepted on those matters as well as others. [Editor's Note: A revised version of Rep. Henry Waxman's (D-Calif.) legislation to create a regulatory pathway for follow-on biologics is expected to be introduced early in the new congressional session ( ² "The Pink Sheet" Oct. 30, 2006 , p. 7).]

Fair Deal On User Fees

"The Pink Sheet": You talked about a coalition on data mining issues. BIO has been part of a coalition on FDA funding - how has that been going?

Greenwood: As we began the PDUFA negotiation process, we looked at the fees and observed that in the first year of the program the fees accounted for 7 percent of the human drug approval budget and it's now about 59 percent. Based on those trend lines, at the end of this next five-year reauthorization period, we'd be at close to 70 percent.

We think that wasn't the original intent of Congress. Obviously, the PDUFA fees were meant to supplement but not supplant the federal funding. What's happened is that Congress has continually added to the mission on the FDA without proportionately adding appropriations. So we think that a fairer deal would be something closer to 50/50, where the fees provide half, which I think is still far more than I think Congress imagined back in 1992...

We created a coalition. [Former HHS Secretary] Tommy Thompson is our chairman. We've brought on [the Pharmaceutical Research and Manufacturers of America], and the food people, and the cosmetic people, and consumer groups and patient groups and so forth. There are about 40 members now.

I've meet with [Office of Management and Budget Director] Rob Portman and made the case strenuously. Obviously [FDA Commissioner Andrew] von Eschenbach is strongly in support; he's keenly aware of the lack of funding at the agency he's now heading. [HHS Secretary Mike] Leavitt's been very, very supportive. Certain members of my board and I met with him earlier last year...

Of course, the problem is that the administration is really bent on deficit reduction, so it's hard to get increases for anything. I've had a conversation with [White House advisor] Karl Rove, so we'll see.

We're cautiously optimistic that we'll get some increase beyond what we could have otherwise, but it's a pretty tough climb to get that from the administration.

"The Pink Sheet": At the board meeting you just had, were there any new priorities for BIO going into 2007?

Greenwood: We're actually in the process right now of working on our work plan for 2007. I'm not sure there is a lot new. I think we'll obviously be playing a little more defense that usual, than we have been in the past on things like drug importation.

Patent reform is a challenge. It was in the last Congress; it will be in this Congress. We've got a situation where the information technology companies have a different ethos when it comes to patents and they would like to change the patent laws in ways that we think weaken intellectual property protections...

We'll continue to work on SBIR, the small business innovation research grants to try and change the process there ... There was an administrative law judge ruling that said that companies that have a majority of their revenues coming from venture capital would not be eligible for these funds. So we're going to try to change that in 2007.

- Cathy Kelly and Nielsen Hobbs