Category: Life Sciences
Sequestration: The Ripple Effect on the Life Sciences Industry
With sequestration scheduled to take effect today, the looming cuts to the U.S. Food and Drug Administration are concerning for the whole of the life sciences industry. The budget sequestration will cut 8.2% from the federal budget, resulting in about $320 million less in spending for the FDA in FY 13 than it had in FY 12. This will put pressure on the FDA to furlough or lay-off employees. The concern is that these effects will result in slower drug and device approvals, and substantially hamper product development.
The Prescription Drug User Fee Act (PDUFA) law, passed by Congress in 1992, allows the FDA to collect fees from drug manufacturers to fund the new drug approval process. This added funding source allowed the FDA to increase the number of new drug reviewers by 77% in the first eight years of the … Read More »
Affliction and Social Media
Tasteless comments about the growth of social communication often fall back on the hackneyed metaphor of “spreading like a cancer.” The growth is uncontrolled, we are told, metastasizing in unexpected locations with ruthless speed. The body politic, we are told, is being rotted within by mutation. The traditions of the past are under siege, and we require radical surgery for a cure.
The panic is unwarranted, but the metaphor may be more apropos than we realize.
The astonishing (and Pulitzer Prize–winning) The Emperor of All Maladies describes the halting progress made in the fight against cancer since it was first identified by the Egyptian physician Imhotep 4500 years ago. For most of that grim history, cancer has been misunderstood, misidentified, and a hopeless diagnosis for its victims. Research was driven by a small number of obsessed, charismatic individuals, many of whom were … Read More »
Are Biosimilars the Next Generation of Small Drug Manufacturers?
New reports suggest that while generic drug makers are aggressively consolidating in the United States and United Kingdom, smaller generic drug manufacturers’ viability is threatened, forcing them to seek niche therapeutic areas. Manufacturing biosimilar biologicals may be an answer for the smaller generic drug companies, due to several factors. First, while manufacturing complexities create market entry barriers, recent shortages of the biologics supply in the U.S. have increased the market demand. Also, low margins are causing large manufacturing companies to exit the biologics market. Furthermore, the patents for many top selling biologics will expire in the next 3 to 5 years, creating an opportunity for new market entrants. Finally, the new abbreviated approval pathway for biosimilars in the U.S. may be more conducive to the needs of smaller firms: efficient approval process, lower development costs, and protection for first generation biologics.
Background
In … Read More »
Electronic Health Records: Looking Past Skepticism
With more instances of Electronic Health Record (EHR) data breaches popping up in the news, skepticism is beginning to build as to whether or not the health care industry can handle the switch from paper to digital. In the most recent incident, The Surgeons of Lake County, located in northern Chicago, fell victim to a data breach by hackers who were able to gain access to e-mails and electronic medical records. Adding to the nation’s interest in this specific incident, the hackers have encrypted the data, holding it “hostage” for ransom from the health care facility. The hackers are demanding payment in exchange for a password that will allow doctors to regain access to their patients’ electronic health records.
Aside from data breaches, EHRs have come under fire for other kinks and flaws related to their implementation. In late July, a … Read More »
Social Medicine?
It isn’t difficult to see that the main impact of social media penetration in our culture is an epidemic of oversharing. Americans under the age of 25 have a very different approach to privacy than, say, your average 30 year-old, and feel weirdly comfortable sharing details of their private lives. E-mail is considered to be outlandishly formal, large scale sharing over social networks and texting is commonplace, and the barriers between personal and institutional communication are nearly non-existent.
This has led, predictably, to mass sharing of medical information online — even two years ago, news organizations were reporting on the rise of “e-patients” who talk to medical experts and amongst themselves in order to obtain treatment, piece of mind and/or the thrill of exposure.
Suddenly, there is widespread information about adverse outcomes and side effects, in every search that someone does for … Read More »
First-Ever Electronic Medical Records and Advanced Imaging Technology Being Brought to 2012 London Olympics
For the first time in Olympic history, advanced imaging technology will be used to help detect athletes’ use of performance-enhancing drugs. GE Healthcare Life Sciences’ biomolecular imager will lend a big hand in helping to test athletes for recombinant erythropoietin (EPO), a performance-enhancing drug used to boost the number of red blood cells, which enables improved oxygen flow and allows athletes to raise their workout intensity and endurance. The GE provided equipment, the ImageQuant LAS4000, uses technology that offers extremely detailed information to accurately identify EPO doping. We first saw the popularity of this drug grow among Tour de France cyclists.
Many other tests will be performed, in addition to the EPO test, in an attempt to create the most advanced drug testing laboratory in the history of the Olympics. GlaxoSmithKline will be the official lab services provider for the 2012 Olympic and … Read More »
U.S. Supreme Court’s Affordable Care Act Decision: Impacts on Life Sciences
The June 28, 2012 U.S. Supreme Court decision upholding the Patient Protection and Affordable Care Act (“Act”) impacts the life sciences industry in a number of ways, including impacts on innovation and compliance initiatives by medical device, pharmaceutical, and biotechnology companies.
Innovation
A number of provisions in the Act provide incentives and resources for product innovation. First, it is expected that more than 30 million Americans will obtain health care coverage on account of the Act. A bigger pool of Americans with health coverage to pay for treatment will yield growth in pharmaceutical sales and, perhaps, the ability to charge higher drug prices, which, in turn, could spur innovation. In addition, the Act created the Therapeutic Discovery Project Program, through which $1 billion in new therapeutic discovery project grants and tax credits will be awarded. In 2010, 2,923 companies specializing in biotechnology … Read More »
Drug and Device Development Outsourcing
As companies outsource drug and device development overseas, reducing development time and research and development costs, additional legal concerns are raised. Last month a Shanghai court sentenced a researcher, employed by a leading Chinese pharmaceutical research firm, with 18 months’ probation, and ordered the employee to pay restitution for stealing and selling two patented compounds, owned by Merck.
The compounds were developed at the research firm, on behalf of Merck. Apparently the employee gained access to the compounds and sold them illegally. This case raises two important issues for manufacturers who outsource. First, can the outsourcing agreements with research firms adequately protect intellectual property rights and data from this type of misappropriation? Secondly, do patent portfolio strategies need to take into consideration these types of risks? To learn more about the case see the article attached….
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World’s First Stem-Cell Drug Approval Achieved in Canada
On May 17, 2012, Osiris Therapeutics announced that Canadian health regulators approved Prochymal, its drug for acute graft-versus host disease in children who have failed to respond to steroid treatment. Prochymal is the first stem cell drug to be approved anywhere in the world for a systemic disease. Graft-versus-host disease, a potentially fatal complication from bone marrow transplant, involves the newly implanted cells attacking the patient’s body. Until now, there have been no approved treatments for the disease. Prochymal is designed to control inflammation and promote tissue regeneration. Since the drug is made up of bone marrow stem cells derived from an adult donor, it circumvents ethical concerns that are raised by the use of stem cells derived from embryos. The Canadian approval is contingent on Osiris conducting further post-market testing—and it’s anticipated that if the FDA approves the drug when … Read More »