Insight on FDA-regulated Industries

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

It’s 12 Years of Data Exclusivity

Wednesday, March 31st, 2010

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…)

Posted in Drug Approval and Access, FDA and Congress, FDA and Industry, Follow-on Biologics, Insight on FDA-regulated Industries | No Comments »

Follow-on Biologics: 1-2-3-GO

Sunday, March 21st, 2010

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…)

Posted in FDA and Congress, FDA and Industry, Insight on FDA-regulated Industries, Planning for FDA's Future | 1 Comment »

Shaken to the Core: What FDA and FDA-Regulated Companies Can Learn from Toyota

Thursday, February 25th, 2010

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…)

Posted in FDA Accountability and Transparency, FDA and Congress, FDA and Industry, FDA Leadership, Insight on FDA-regulated Industries | No Comments »

Transition at PhRMA

Sunday, February 14th, 2010

Former Representative Billy Tauzin tendered his resignation this week, ending a 5 ½ year tenure as President of the Pharmaceutical Research and Manufacturing Association (PhRMA). When his successor is chosen, it will tell us a lot about how the pharmaceutical industry sees itself….and what the big pharmaceutical companies think is their next major challenge. Here is FDA Matters’ analysis. (more…)

Posted in FDA and Industry, Insight on FDA-regulated Industries | No Comments »

Has FDA Slipped Back into Anti-industry Mode?

Wednesday, January 13th, 2010

An industry CEO wrote me to observe: FDA is returning to the anti-industry paradigm of the past. His concern is understandable. Yet, I respectfully disagreed with him. It is natural to fear change. It is easy to confuse activism with ideology.

FDA Matters believes there are two perspectives from which to judge the situation of FDA versus industry. (more…)

Posted in FDA and Congress, FDA and Industry, FDA Leadership, Food Issues, Insight on FDA-regulated Industries | No Comments »

Messages to the FDA-Regulated: Seven Columns to Re-read for 2010

Sunday, January 3rd, 2010

This past year has been a tumultuous one for FDA-regulated industries as they struggled to provide new and safer medical products and safer foods, while weathering much criticism.

FDA Matters has explored a number of industry issues in 2009. As they evolve in the new year, I will continue to provide readers with my analysis and commentary. Meantime, here are seven columns that provide insight about FDA-regulated companies. They provide useful background for 2010: (more…)

Posted in Drug Approval and Access, FDA and Industry, Follow-on Biologics, Insight on FDA-regulated Industries | No Comments »

Off-Label Uses Need to Become On-Label Indications

Friday, December 18th, 2009

A friend asked: what advice would you give a pharmaceutical company in the late stages of developing a new product that will be widely used off-label? The company’s concern was that FDA might hold the first use to a very high, perhaps unrealistic standard to protect patients that might receive the drug off-label after approval.

In thinking about how FDA views this type of situation, I realized there were two very concrete things the company could do. Here is the FDA Matters analysis: (more…)

Posted in Drug Approval and Access, FDA and Industry, FDA Leadership, Insight on FDA-regulated Industries | No Comments »

Internet Communications: FDA Needs to Divide the Issues to Conquer the Problem

Wednesday, December 2nd, 2009

Creating an Internet communications policy for regulated medical product companies is so daunting that FDA has largely ignored the responsibility. November’s FDA hearing on social media was an important step, but offered no sign that new policy will be announced anytime soon.

FDA needs a different approach. This is not a matter of a large, complicated problem with many facets. Rather, it is a number of smaller problems that can be addressed separately. (more…)

Posted in FDA and Industry, FDA Leadership, Insight on FDA-regulated Industries | No Comments »

Executions in China: A Thanksgiving Message

Tuesday, November 24th, 2009

Sometimes it takes other people to give us a perspective on our own values. (more…)

Posted in FDA and Industry, FDA Leadership, Insight on FDA-regulated Industries | No Comments »

Black, White, Shades of Gray

Friday, November 13th, 2009

Civil and criminal investigations are becoming a more prominent feature in the world of FDA-regulated industries. People who never gave any thought to this….suddenly find themselves needing to understand how investigations work.

Being FDA-regulated means “always worrying that you will have to say you’re sorry.” But it matters whether you are apologizing to FDA or trying to apologize to investigators. (more…)