FDA Matters Blog

Archive for the ‘Insight on FDA-regulated Industries’ Category

NIH and Drug Development: Dr. Collins’ New Initiative

Sunday, January 30th, 2011

Dr. Francis Collins, director of the National Institutes of Health (NIH), wants to create a new National Center for Advancing Translational Sciences (NCATS) at NIH.  The new Center would combine $700 million in existing NIH projects with, perhaps, an additional $300 million from new monies or other NIH programs. NCATS is intended as NIH’s “response” to the biopharmaceutical industry’s failure to produce more new drugs.

FDA Matters doesn’t see the sense of creating a public sector drug development company. Nothing suggests that government has either the requisite knowledge or experience to succeed. Yet, several people I respect are supportive of Dr. Collins’s initiative. (more…)

Will the New Congress Be Good for FDA-Regulated Industries?

Sunday, December 19th, 2010


FDA Matters is hearing that FDA-regulated industries will benefit from the 2010 election. It is assumed that a Republican-led House and more Republicans in the Senate will benefit drug, device and food companies. After all, aren’t Republicans more business-friendly and more concerned about perceived regulatory excess?

Those saying and thinking these things may be in for a rude awakening. Even worse, they may find themselves nostalgic for the "good old days" (whenever those were). Everybody—FDA, industry, patients and consumers—is going to have a rough time over the next two years. Industry will be heard more often, but not always have the winning position. (more…)

FDA: A Hit and A Miss

Sunday, September 26th, 2010

FDA Matters has watched FDA handle the Avandia decision differently from any prior controversy. I like the new approach. In the same week, FDA provided a status report on its long-overdue social media and Internet communications policy. Because the agency’s efforts have been glacial, the prospect of useful guidance is dim. I think this is a serious problem. (more…)

PhRMA’s Choice: A Man for All Reasons?

Tuesday, July 13th, 2010

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…)

FDA, Female Sexual Desire and the Media

Sunday, June 27th, 2010

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…)

FDA to Industry: Contractors R U

Thursday, June 17th, 2010

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…)

Quality Control Woes: What’s a CEO to Do?

Wednesday, June 2nd, 2010

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…)

Orphan Drugs and Bio-Similars: Is 12 Better than 7?

Sunday, May 16th, 2010

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…)

Data Exclusivity and Bio-Similars: Both More and Less Than It Seems

Sunday, May 2nd, 2010

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…)

Clinical Trials: Gold Standard In Need of Improvement

Sunday, April 11th, 2010

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…)

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