The Pharmaceutical Research and Manufacturers of America (PhRMA) has announced John Castellani as its new CEO and President. For the past 9 years, he has been the head of the Business Roundtable, a very successful association of corporate CEO’s.
History tells us that the choice of a new PhRMA President will reflect the Board’s view of the state of the industry and its most pressing needs. The new appointment continues that tradition. (more…)
This week’s hottest bio-pharmaceutical story was the June 18 FDA advisory committee’s review of a drug to treat hypoactive sexual desire disorder (HSDD). The committee did not recommend approval of the drug, but encouraged the sponsoring company and others to continue working in this area.
What struck me most was the contrast between the seriousness of the advisory committee in deciding whether the treatment was safe and effective in treating a genuine medical disorder and the inability of the American media to report the story objectively or sympathetically. (more…)
It seems a rather uncontroversial proposition: FDA-regulated companies are responsible for their vendors, including every contracted piece of work that is done on the company’s behalf. If problems develop, it makes no difference whether a company did it…or a contractor did it for them. Two seemingly unrelated items this week suggest that FDA is becoming concerned about whether FDA-regulated companies are overseeing their vendors. (more…)
Medical products companies are struggling to assure FDA and the American people that their products are “safe as manufactured and distributed.” We don’t know whether quality control has become lax, FDA is discovering more problems or industry has just had a run of bad luck.
We do know that quality control relies on a lot of people maintaining tough standards…and that manufacturing is rarely a priority of a drug and device company CEO. Earlier this year, in the wake of Toyota’s problems, FDA Matters asked: “what’s a CEO to do?” (more…)
In the new bio-similars legislation, orphan drugs were granted protection for the longer of 12 years of data exclusivity or 7 years of market exclusivity. Since both are triggered by the date of approval, many people have assumed that 12 years protection is always better than 7 years protection.
FDA Matters says: not so. Other than patent protection, the Orphan Drug Act’s grant of market exclusivity to orphan drugs is still the best friend of an innovator company. (more…)
FDA Matters has been very upbeat about the prospects for the bio-similar marketplace. “Smart money” (i.e. companies currently making billions from their ability to discover or license new bio-pharmaceuticals and market them) decided to play before they knew the ground rules on exclusivity and patents. We can only conclude that there must be substantial amounts of money to be made, regardless of the specifics.
With this in mind, FDA Matters explores why there is a persistent belief that the bio-pharmaceutical industry got something better than data exclusivity. I also explore whether data exclusivity will really provide valuable protection for original reference biologic products. (more…)
There is an emerging crisis in the development of drugs, biologics and complex new medical devices. Clinical trials take too long, cost too much and often produce imperfect knowledge. Many promising medical products are not developed because of the difficulty and expense of proving safety and efficacy—a loss that is costly to society.
FDA Matters believes that the key lies in developing new approaches to generating rigorous data and analysis. Ultimately, this will require the re-invention of the clinical trial. (more…)
For an updated analysis, go to the May 2, 2010 column: Data Exclusivity and Bio-Similars: Both More and Less Than It Seems.Read the rest of this entry »
On several occasions, FDA Matters has asked Congressional staffers: how many of the Senators and Representatives understand that the follow-on biologics debate is about the amount of data exclusivity, not market exclusivity? In reply, I always get a smile that confirms my suspicion.
The confusion is not limited to the Hill. The New York Times referred to “market exclusivity” in its article on industry winners and losers on the day of the key House vote. A prominent industry trade publication—whose staff clearly knows better—referred to “bullet-proof market exclusivity” in a story the next day. The San Francisco Chronicle got it right—perhaps because of the concentration of bio-pharmaceutical companies in the Bay Area.
None of this would matter if data and marketing exclusivity were similar to each other…or even of roughly equal value. They are not. The future of bio-similar products cannot be understood without grasping the difference. (more…)
The long fight is over for follow-on biologic (FOBs). The Senate-passed version of health reform will become law, even while the larger fight continues over the reconciliation package. Within 10 days, FDA will be busy implementing an approval pathway for FOBs.
The world of biopharmaceuticals will never be the same, but not in the ways that many players expect. Here is FDA Matters’ guide to understanding the next phase. (more…)
I do not believe that Toyota became a global success by cutting corners and ignoring safety concerns. Nonetheless, the company may not survive the investigations, the lawsuits, the civil and criminal fines, the securities litigation, the recalls (8.5 million cars so far), the loss of consumer confidence and the possible criminal indictments.
FDA Matters hopes that the CEO’s of FDA-regulated companies are paying attention. They need to understand that their company can be “shaken to the core,” as Toyota has. (more…)
