This letter concerns the FDA press release dated January 18, 2006, entitled "FDA Announces New Prescription Drug Information Format to Improve Patient Safety." The information contained is considered false and misleading, and lacking in fair balance.
The US drug regulatory system fails to address the country’s most urgent medical needs with the resources appropriate for the task. But change is possible.
No brand manufacturers plan to market generic versions of their own product, at least not until the patent expires. And why would they? As long as the branded version enjoys patent protection, marketing a cut-rate product would eat away profit margin during the years when a drug makes the most money.
Accept distortions and untruths. Don't try to undo them. The point is not to win an argument; your critics' views are legitimate, irreversible realities. It's time to give the public something new to think about.
Even though data can single out physicians with high marketing upsides, most pharma companies are doing without such high-value data.
Cost-shifting is still one of the favorite tools in almost all employers' cost-cutting toolboxes. But many fear that shifting too many costs to workers will backfire. Low co-pays keep people healthy and on the job: a big return on investment.
In today's "show me the money" marketplace, reimbursement strategy must innvolve more than seeking a good price based on ability to pay.
Sales reps should be able to access, in a central location, company-enerated influences that have affected a given physician. This type of closed- loop marketing creates a more customer-centric approach that provides etter influencer-level insight by connecting each resource, providing direction and metrics, and continually re-evaluating key influences and ROI.
Even though data can single out physicians with high marketing upsides, most pharma companies are doing without such high-value data.
Plantiffs did not try to establish a link between the purported misconduct and the decline in share price. Rather, their sole allegation was that they had paid artificially inflated prices for Dura securities.
Every quarter, pharmaceutical manufacturers confront a dizzying array of price reporting obligations. Participation in the Medicare, Medicaid, Veterans Administration (VA), and Public Health Service (PHS) programs requires manufacturers to collect, organize, distill and manipulate vast quantities of information, and to generate from that data reportable figures that can have an enormous impact on the company's bottom line. It is critical that these figures be correct, not only to help ensure the integrity of these public programs, but because submission of false data to a federal agency is a prosecutable criminal offense, and the civil penalties and exposure can be staggering.
Having an efficient, integrated call center can be a matter of life or death. Imagine a pharma company not knowing for several weeks that the active ingredient in a life-saving drug was left out of the final product? How would they learn of the error if the quality control at the manufacturing plant failed to identify the problem? Most likely, the next opportunity for identifying such a crisis is through the call center-the key interface between healthcare professionals, consumers, and the company. However, it's not enough to log complaints about a product's efficacy. Once documented, complaints need to be routed to the right department, evaluated, and consolidated. If a streamlined process isn't in place, weeks could pass without anyone ever taking any action-even as adverse event records pile up.
In 2005, healthcare advertising hit a new level of refinement in strategy and sophistication in execution. Even better, it reached a new place, where promotion and education sit comfortably together. Brand teams are growing and learning, particularly about using emotion to inspire action.
The relaunch team focused on clinical differentiation to drive business with science.
With little momentum in developing new new antibiotics to fight antimicrobial resistance, the time is now to emphasize "push" and "pull" incentives and demonstrate how innovation in this area will lead to patient benefit and economic reward.
Without common reporting standards in place, researchers have little incentive to share data with scientists elsewhere in the company. When researchers don't sharedata on a regular basis, they can begin to feel proprietary about their work-and even less inclined to disclose their results.
As the prevalence of falsified medicines continues to increase, Switzerland is taking measures to secure its supply chain such as the implementation of serialization.
Insurance contracts are a language game that must be played very carefully, as AstraZeneca learned.
THE OLD FORMULA IS TRIED AND TRUE: GET YOUR reps informed and excited at a launch meeting, and you'll have a positive impact on the success of the drug. But too many pharma meeting planners forget that sharp PowerPoint slides and fancy dinners no longer impress sophisticated sales reps. Reps want more than a fresh presentation. They seek a new experience. They want to be wowed.
At the Division of Drug Marketing, Advertising, and Communications (DDMAC), our goal is to assure that prescription drug promotion is not false or misleading, and that it presents a balanced picture of a drug's risks, as well as its benefits.
When Pfizer CEO Jeffrey Kindler took the podium in January and announced that the struggling company would scale back and restructure its operations, he did more than just signal the end of an era. He proved that to turn around Pfizer-and in a way, the industry at large-companies need to hack away the parts that just aren't working anymore.
Companies are in a near-impossible situation-trying to define, follow, and track existing and pending legislation.
Despite Rituxan's initial success, the brand team considered the long-term opportunity for future indications. Equity research studies demonstrate that a significant "halo" exists around the brand, which is bolstered by greater optimism and excitement for all B-cell mediated conditions.
A study of doctors uncovers the hard facts behind what professional sales strategies work
Pharmaceutical companies doing business in Europe had better heed EU antitrust laws. It does not take a genius to devise a cartel.
More consolidation didn't boost sales at the top, but a handful of nimble newcomers posted impressive growth on the other end of the curve.