Sunday, March 25, 2007

Phrase of the Day

PB learned a new phrase today, while catching up on George Will columns - "rent-seeking." OK, I've actually heard it before, without necessarily knowing what it meant, and I'm sure you business school types are scoffing at PB's ignorance.

It is not true that businesses, as a matter of principle, want to fend off government regulation. Businesses have a metabolic urge to make money, which is as it should be. But when a compliant government gives them the opportunity to use government regulations to enhance their moneymaking, that metabolic urge will overpower any principles about the virtues of free (from government intervention) enterprise.

Sound like anyone we know?

BTW, note the link on the right from the page above for the Pat Sajak columns. Did you know Pat was a columnist? PB is having an enlightening weekend.

Saturday, March 17, 2007

March 15 WSJ

By the way, if you can find a copy, pick up last Thursday's Wall Street Journal to read the front page article on cancer drug pricing. You can read a blurb here, in addition to some reader comments. I was considering commenting, but just about everything was said. I might add to the poster ("JIM") who is concerned about the economics knowledge of WSJ readers - Investigate how long it takes Pharmas to recoup that $1 billion investment. Not too long, folks. And how much of that $1 billion is real, how much is NIH, etc.

Friday, March 16, 2007

Face to face

So, we'll be traveling next week up the turnpike to see counterparts from another Big Pharma, negotiating safety data exchange agreements. Or rather, observing the negotiation. This is PB's first face-to-face with another company. Yes it's true - PB is an underachiever, so to speak. I came into this racket late, after wasting a few years with more menial jobs. Now I'm not a youngster anymore, and I'm feeling it.

Anyway, the big legal issue with licensing for us has to do with reporting timelines, and the EU. Volume 9A, the European Commission's guidance document on pharmacovigilance (PV) was published in late January, and the big hit in licensing has to do with individual case handling reports (ICHRs). Specifically, the guidance explicitly states in Part 1, section 4.2, that the reporting clock date is set at "0" whenever the Marketing Authorisation Holder company or any company with a contractual arrangement with the MAH gets information about a adverse event. Ouch. Up until now, our practice has been to consider Day "0" the day when our company gets the report from our licensing partner. The deadline is day 15 - these are calendar days, not working days. So now we have to factor in much shorter data exchange timelines with other companies, and re-negotiate existing agreements.

Unfortunately, we don't have any electronic data exchange with our licensing partners. Our ability to do this is hampered by a lack of shared/compatible data standards and systems, and strained IT budgets. We're faxing and e-mailing case reports back and forth. We're doing this after the case has been entered into our own system, with our own internal timelines. Those internal guideline are geared toward our own company getting the reports in by day 15, not worrying about another company needing to do the same thing. Really, it's substantially shorter than 15 days already, because we've got to make the reports available to our marketing companies around the world, so they can submit the reports (usually a CIOMS) to their regulators.

So now, we have to decide either 1. Rework our individual case handling procedures to shorten our internal timelines, and expect our licensing partners to do the same, or 2. Assign one or the other of the companies to handle all of the reporting duties of a co-marketed drug to all of the regulators around the world, or 3. Share all source materials about adverse events with our partners the day they are received, and trust each party to send reports to their respective parts of the world's regulators

In reverse order, Number 3 is a non-starter, because our two companies could have completely different opinions on a case, if it's regulatory serious, listed with our core data sheet, etc. Then we would have two versions of the same case submitted to agencies, which would be a legal nightmare. We'd also never be able to produce a PSUR with competing cases.

Number 2 above can work fine if we're dealing with another large Pharma with established international reporting. They can do the case handling, submit the IPARs and QLLs to the Europeans for us, etc. The company I'm visiting next week can most likely do all that. But it gets really ugly when you've done a licensing deal with a company that only covers one country, like the US. If your licensing partner in the US is only selling your drug here, they have no reason to submit anything to European regulators. They may not even have the means to do so. And they probably won't tighten their internal timelines to get ICHRs to us quickly, so that we can.

So, we're often stuck with option 1, which is chaos and scrambling, or making exceptions for this or that product received from this or that source. Forget harmonization of processes. Or, my personal favorite variation on option 1, streamline your processes to cut out review times of ICHRs. Just type the case in and send it. This would put our reviewing physicians in a snit, but too bad. My company has too many reviews on an ICHR anyway. We've done some recent benchmarking, finding that other companies are just sending the reports, and worrying about medical review later.

But we know that *others* (Dr Wolfe, big law firms, David Graham at FDA) are scrutinizing our ICHRs, and our goal is to get the MedWatch exactly accurate before they go out the door the first time, being very careful with our wording. Franky, if you read my last couple of posts, it doesn't seem to be making any difference. We're under siege as it is, regardless of what we submit.

Sunday, March 11, 2007

Not much. What's new with you?

Legions of readers have been asking, so PB, what's been going on with you?

Well, we're happy to say we've conned ever more people into thinking we're doing a good job at work, and we're looking at a promotion within the next few months. There's cutbacks in other parts of the company, so that means that additional justifications have to be made for promotions, new hiring, etc. Really, that means that delays are built into the process, so we don't look so callous to managers who have to let people go. The company can say with some plausible deniability that they are not blatantly ignoring the company's bottom line by promoting PB when others elsewhere are being shown the door.

So, why are some people out the door? Over capacity created by incorrect forecasts, which were made incorrect by some high-profile late stage trial failures. Big ones. A shame - those were the products that actually made us proud to be in this business. They were innovative science, new approaches to unmet needs, etc. They just didn't work, was all. Details, details....

Legal Assault

Ouch - over 1000 adverse event report in the past week and counting, all submitted by law firms for one product of ours. Our drug safety group has been scrambling to get these cases in the database on time, asking overseas offices to assist in the data entry, working weekends, etc. Deadlines will be met, according to the Veep of the department.

The reports for this particular product have been rolling in for about a year. We've got about 8000 total legal reports with named patients. If you've read Grisham's The King of Torts, then you have some idea about how this works. Now I'm seeing it from the other side.

If you Google the brand name of this product, about 3 or 4 of the top 2o hits are for law firms, but almost all of the Sponsored links are for lawyers. It's also under investigation by Pennsylvania for off-label marketing. This is a huge franchise, and we're counting on line extensions to keep sales up for at least 10 more years. It's a shame that a product becomes more well known for the negative news it generrates than any actual good it has done for patients.

We have little advance warning about when to expect discs arriving from a law firm with hundreds or more cases, but we haven't had to cry uncle yet. Still, the resource drain is huge.