FDA, Female Sexual Desire and the Media
June 27th, 2010This 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. Read the rest of this entry »
FDA to Industry: Contractors R U
June 17th, 2010It 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. Read the rest of this entry »
Is the New FDA Different than the Old FDA?
June 13th, 2010Two weeks ago, FDA Matters explored Dr. Hamburg’s legacy, focusing on advocacy for resources, prioritizing regulatory science and upgrading enforcement. These will be accomplished before she leaves office. But is she making similar progress in creating “a new FDA?” Read the rest of this entry »
Quality Control Woes: What’s a CEO to Do?
June 2nd, 2010Medical 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?” Read the rest of this entry »
Not Too Soon to Consider the Hamburg Legacy
May 27th, 2010May 18 marked one year since Dr. Margaret Hamburg was sworn in as Commissioner of the US Food and Drug Administration. The challenges are great, the torrent of issues is never-ending and most days you can smile but you can’t win. Nonetheless, I think it has been a very good first year for her and for Principal Deputy Commissioner, Dr. Joshua Sharfstein.
It may seem premature to be discussing “the Hamburg legacy.” But you know that she is thinking about it (all commissioners do), so why can’t FDA Matters talk about it? Read the rest of this entry »
“Safe”: Many Meanings Complicate FDA Policymaking
May 23rd, 2010FDA Matters is in favor of safe foods and safe medical products. Who isn’t? If you are a consumer, maybe that’s all that matters.
However, being in favor of safe foods and safe medical products is not enough if you are FDA, the media, Congressional authorizers and appropriators, OMB, and industry. It sounds good, but what does it really mean? In the FDA context, “safe” means many things, some of which are barely related to each other. Read the rest of this entry »
Orphan Drugs and Bio-Similars: Is 12 Better than 7?
May 16th, 2010In 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. Read the rest of this entry »
Dissent and Efficiency: Difficult Trade-offs for FDA
May 9th, 2010FDA has a reputation for being tough on dissent, whether it comes from employees or regulated companies. It is often alleged that FDA employees with contrary views are re-assigned, marginalized or ousted. Within the regulated industries, there is a widespread belief that arguing with FDA has adverse consequences for a company.
Whatever the truth has been in the past, FDA is trying to develop an institutional cultural that welcomes and accepts dissent from employees, industry and other stakeholders. It is difficult, even messy, to do this. Yet, FDA’s reputation and authority rests on showing that it listened to all competing views–without unreasonably slowing the decisionmaking process. Read the rest of this entry »
Data Exclusivity and Bio-Similars: Both More and Less Than It Seems
May 2nd, 2010FDA 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. Read the rest of this entry »
Center-Envy: Are Foods Doing Better than Drugs?
April 25th, 2010Several times this year, I have been told: FDA’s food activities have been getting most of the new monies at the expense of human drugs (CDER) and biologics (CBER). But is it true that food activities (mostly CFSAN, the Center for Food Science and Applied Nutrition) are receiving preferred treatment?
FDA Matters ran the numbers to see. We conclude that center-envy is bad in its own right, but even worse when it is based on misinformation and misperceptions. Read the rest of this entry »
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