Pharma industry awaits impact of Obama’s second term

Now that the American people have spoken—with about 120million votes estimated to have been cast as we went to press with this issue—andreelected President Barack Obama to a second term, many of you may be asking,"How will this affect pharma?"

It's a heavy question, given how the passage of the PatientProtection and Affordable Care Act (PPACA) during the president's first termalready has the pharma and biotech industries busy assessing how to do businessin a new healthcare paradigm. But with many facets of the new law taking effectas the president's second term begins, tongues are wagging, and all eyes are onthe phasing in of some of the particulars of the 2,000-plus-page bill.

The effect of the PPACA might be a blessing and a curse, inthe view of some. Although more insured patients may mean more prescriptiondrug sales, a push to reduce public spending and rebates on drugs for seniorsin the Medicare Part D coverage gap may also mean decreased profits. Theauthorization of biosimilars has the potential to change the prescription druglandscape, while the U.S. Food and Drug Administration may be overwhelmed by apush to bring new drugs to market in a timelier fashion.

Aside from the obvious issue of healthcare reform and theongoing stem cell research debate, the president alluded to some of the othergreat challenges facing our nation, some of which will undoubtedly impact thepharma, biotech and life-science industries in profound ways—or so we all canhope.

"We want our kids to grow up in a country where they haveaccess to the best schools and the best teachers," he said in his acceptancespeech, delivered in the early morning hours of Nov. 7. As noted recently byddn columnist Peter T. Kissinger in his August commentary,"August-is-back-to-school month," "much has been written about failing schoolsand our student performance ranking below other nations on standardized testsfor science, technology, engineering and mathematics subjects."

"We are unconvinced that Finland, with its populationsmaller than many American cities and less diverse than a bag of frozen peas,is a reasonable benchmark," Kissinger wrote. "Many gurus respond that scienceteachers should have deeper content knowledge and science as their primarycollege major. That's a noble thought, but the disincentives are many."

Serious challenges abound in our formal education system, aswell. With the cost of college tuition skyrocketing, the pursuit of advanceddegrees is in danger. At the same time, some in the drug discovery ecosystemare beginning to question whether advanced degrees are needed at all. Forexample, a March 2010 Nature editorialposed the question, "Do scientists really need a PhD?" The article cited anexperiment at Chinese genomics firm BGI in which the company hired younguniversity students to perform genomic sequencing duties, few of whom had plansto pursue postgraduate education.

"Would the slower, less tightly focused training provided byWestern-style postgraduate study ultimately allow them to become moreimaginative and creative in their research?" the article queried.

Whether or not our next generation of scientists decides topursue certain advanced degrees, we will still be left with the nagging dilemmaof how to increase innovation in R&D once they do or do not graduate.

"A country that lives up to its legacy as the global leaderin technology and discovery and innovation, with all the good jobs and newbusinesses that follow," Obama noted in his speech.

Much has been written about this topic, in this publicationand in many others. The issues surrounding R&D's shortcomings are varied:the rising cost of clinical trials; regulatory burdens; the "brain drain";patent battles; safety issues; massive pharma layoffs; the outsourcing of basicresearch functions, to name a few. But isn't it time for serious discussions tobe had, with a set of deliverables and a timeline in which to tackle thischallenge? On the cover of this month's issue, you can read about an initiativein Big Pharma to do just that ("All for one, one for all"). TransCelerateBioPharma Inc., a consortium of 10 top pharmas, has formed a plan to eliminatesome of the bottlenecks that cause inefficiencies in clinical trials. That's astart. What else have we got, pharma?

"We know in our hearts, for the United States of America,the best is yet to come," said the president in his acceptance speech. Whilethe identity of our president obviously shapes what indeed is to come, ultimately—likethe electoral process itself—it's really up to us. For those of us whoexercised our right to vote, our work did not stop when we turned in ourballots. No matter who our president is, it's up to we, the people, to look atthe challenges facing this country and this industry and decide what to doabout them.

"Therole of citizen in our democracy does not end with your vote," the presidentstated. "America's never been about what can be done for us. It's about whatcan be done by us together through the hard and frustrating, but necessary workof self-government. That's the principle we were founded on."

And in his concession speech, Obama's opponent, Mitt Romney,made a similar push for us all to pull ourselves up by our bootstraps: "This election is over, butour principles endure. I believe that the principles upon which this nation wasfounded are the only sure guide to a resurgent economy and to a renewedgreatness."

Here's to four years of prosperity, collaboration andinnovation, and all of the newsworthy stuff it takes to get there.