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Pharma industry awaits impact of Obama’s second term
Now that the American people have spoken—with about 120 million votes estimated to have been cast as we went to press with this issue—and reelected 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 Patient Protection and Affordable Care Act (PPACA) during the president's first term already has the pharma and biotech industries busy assessing how to do business in a new healthcare paradigm. But with many facets of the new law taking effect as the president's second term begins, tongues are wagging, and all eyes are on the 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, in the view of some. Although more insured patients may mean more prescription drug sales, a push to reduce public spending and rebates on drugs for seniors in the Medicare Part D coverage gap may also mean decreased profits. The authorization of biosimilars has the potential to change the prescription drug landscape, while the U.S. Food and Drug Administration may be overwhelmed by a push to bring new drugs to market in a timelier fashion.
Aside from the obvious issue of healthcare reform and the ongoing stem cell research debate, the president alluded to some of the other great challenges facing our nation, some of which will undoubtedly impact the pharma, biotech and life-science industries in profound ways—or so we all can hope.
"We want our kids to grow up in a country where they have access to the best schools and the best teachers," he said in his acceptance speech, delivered in the early morning hours of Nov. 7. As noted recently by ddn columnist Peter T. Kissinger in his August commentary, "August-is-back-to-school month," "much has been written about failing schools and our student performance ranking below other nations on standardized tests for science, technology, engineering and mathematics subjects."
"We are unconvinced that Finland, with its population smaller than many American cities and less diverse than a bag of frozen peas, is a reasonable benchmark," Kissinger wrote. "Many gurus respond that science teachers should have deeper content knowledge and science as their primary college major. That's a noble thought, but the disincentives are many."
Serious challenges abound in our formal education system, as well. With the cost of college tuition skyrocketing, the pursuit of advanced degrees is in danger. At the same time, some in the drug discovery ecosystem are beginning to question whether advanced degrees are needed at all. For example, a March 2010 Nature editorial posed the question, "Do scientists really need a PhD?" The article cited an experiment at Chinese genomics firm BGI in which the company hired young university students to perform genomic sequencing duties, few of whom had plans to pursue postgraduate education.
"Would the slower, less tightly focused training provided by Western-style postgraduate study ultimately allow them to become more imaginative and creative in their research?" the article queried.
Whether or not our next generation of scientists decides to pursue certain advanced degrees, we will still be left with the nagging dilemma of 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 leader in technology and discovery and innovation, with all the good jobs and new businesses that follow," Obama noted in his speech.
Much has been written about this topic, in this publication and 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 basic research functions, to name a few. But isn't it time for serious discussions to be had, with a set of deliverables and a timeline in which to tackle this challenge? On the cover of this month's issue, you can read about an initiative in Big Pharma to do just that ("All for one, one for all"). TransCelerate BioPharma Inc., a consortium of 10 top pharmas, has formed a plan to eliminate some of the bottlenecks that cause inefficiencies in clinical trials. That's a start. 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. While the identity of our president obviously shapes what indeed is to come, ultimately—like the electoral process itself—it's really up to us. For those of us who exercised our right to vote, our work did not stop when we turned in our ballots. No matter who our president is, it's up to we, the people, to look at the challenges facing this country and this industry and decide what to do about them.
"The role of citizen in our democracy does not end with your vote," the president stated. "America's never been about what can be done for us. It's about what can be done by us together through the hard and frustrating, but necessary work of 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, but our principles endure. I believe that the principles upon which this nation was founded are the only sure guide to a resurgent economy and to a renewed greatness."
Here's to four years of prosperity, collaboration and innovation, and all of the newsworthy stuff it takes to get there.