COVID-19 has only magnified well known flaws of our healthcare system. An extension of Medicare is the affordable solution, writes Bruno Delagneau, and pharma needs to start planning for this to minimize its impact on US revenues.
Very few drugs live forever. Barring remarkable scientific advances and radical market dynamics, most drugs hit old age-and sharply declining sales-several years before their patent expires. But some drugs go out with a bang, not a whimper.
The need for biopharma executives to combine a "culture of quality" with value-added processes and improvements in the area drug manufacturing is critical. Here are steps and strategies than can help.
We all know that pharma is facing hard times: cut-throat competition, regulatory constraints, patent expirations, rusty pipelines, rising generics, falling revenues-and, perhaps most important, a firestorm of consumer anger over drug prices and safety now being restoked by the new Democratic Congress. Nevertheless, industry persists in "staying the course"-sound familiar?-rather than charting a bold new strategy. Its two top priorities remain opposing government price controls and thwarting patent laws favorable to generics. These defensive tactics are hardly the hallmark of leadership.
Companies that adopt this new methodology will have a longstanding competitive advantage over those companies conducting business as usual.
The federal government's enforcement juggernaut rolls on-and the pharmaceutical industry is squarely within its sights. In recent years, the industry has paid close to a billion dollars in fines, civil settlements, and penalties.
It's time for pharma market research to advance science-based decisions and foster judgement calls
Welcome to the new employer's market for reps. The Hay Group's annual survey reports how, as the primary sales force contracts, so too does its pay.
Patient recruitment for clinical trials is one of the most significant bottlenecks in drug development. As a result, several organizations have called for the establishment of recruitment best practices, beginning in 2000 with the Office of the Inspector General's (OIG) report on recruiting human subjects and most recently in a Clinical Research Roundtable report published in the March 12, 2003 issue of the Journal of the American Medical Association (JAMA).
Very few drugs live forever. Barring remarkable scientific advances and radical market dynamics, most drugs hit old age-and sharply declining sales-several years before their patent expires. But some drugs go out with a bang, not a whimper.
People are up to a thousand times more worried about involuntary risks (living by a cell phone tower) than they are about voluntary ones (using a cell phone). And they see pharma products as involuntary risks.
The history of prescription drug laws is a complex mix of evolution and politics-in particular, the politics following real or perceived public health crises. The bipartisan PDUFA IV legislation currently pending in Congress is no exception: The bills-the Senate FDA Revitalization Act (S. 1082) and the House FDA Amendments Act (H.R. 2900)-would both continue existing programs and create new regulatory burdens.
If it looks too good to be true.... The price is unbeatable, the Web site proudly displays an accreditation seal of approval, medicines are advertised as "generics" of the branded versions (implying bioequivalence with respect to safety and efficacy), and patients never have to leave their homes. Marcia Bergeron, a 57-year-old Canadian resident likely had these things in mind when she purchased antianxiety and sedative medication from an online pharmacy. The pills she received from the Web site, however, caused hair loss and vision problems, and ultimately resulted in her death. The coroner's toxicology report showed that the pills she purchased online were laced with traces of dangerous metals, including uranium, strontium, selenium, aluminum, and arsenic. Bergeron, like many others around the world, was a victim of the counterfeit-medicine business, an industry that the US-based Center for Medicine in the Public Interest (CMPI) predicts will reach $75 billion in sales globally by 2010.
Drug manufacturers came under fire at a hearing of the House Energy and Commerce?s health subcommittee for bumping drug prices 10 percent this year. Pharma claims rumors that it?s boosting costs in anticipation of healthcare reform are baseless, but the industry could be facing an uphill battle.
Avandia's market share erosion was magnified further by the almost complete absence of new prescriptions being switched to Avandia from its competitors. In the weeks before the event, Avandia accounted for more than 20 percent of all switches by primary care physicians
The first wealth is health, wrote American thinker Ralph Waldo Emerson. Indeed, history has taught us (even before Emerson) that health and wealth are inextricably linked-the more money one has, the healthier one is likely to be.
Doctors like direct mail as long as the message is concise and to the point. The minute you ask the doctor to actually do something with the direct mail, that's when your effectiveness starts to go downhill.
Successful pharmaceutical sales and marketing organizations operate much like healthy ecosystems: each interdependent group fills a critical need for the company's growth and survival. (See "Sales and Marketing Ecosystem," ) Yet many pharma com-panies can barely sustain past growth performance, let alone attain a higher level. If the trend continues unchecked, several pharma companies could falter.
Documents from R&D, clinical affairs, regulatory, and sales and marketing can be in the millions. Throw electronic information into the mix, and the number of documents required for litigation increases exponentially.
Is a pharma website a type of labeling, a form of advertising, or some new hybrid? The industry has used the internet as a communication channel since 1994, yet, after nearly a decade of online medical development and experimentation, none of the major regulators has decided yet-or offered any clear guidance about-what constitutes "acceptable use."
Pediatric drugs require investments in formulation, but the market opportunity is worth the cost.
When it comes to clinical teams, the question of whether or not to outsource brings some untraditional answers
How hopeful are execs about the future of their own companies and the industry in general?
When it comes to clinical teams, the question of whether or not to outsource brings some untraditional answers
Whether browsing through magazines or watching television, one doesn't have to look long in order to find a direct-to-consumer advertisement for a prescription medication.
Though it may sound paradoxical, the most effective deployment of a patient-feedback program is within a pharmaceutical brand's professional promotions