FDA Matters Blog

President Obama, Please Retain Commissioner Hamburg

December 4th, 2012

With President Obama’s re-election, many people are sitting back and assuming that the U.S. Food and Drug Administration (FDA) won’t change much. In FDA Matters’ view, it doesn’t need to: Commissioner Hamburg is doing a good job; the agency is moving forward to improve food, drug and device safety; more rational and predictable review processes are being implemented; and there are at least three relatively new laws that need ongoing attention.

However, year five of an incumbent presidency almost always involves changes in personnel and policies, not the continuity one might expect. FDA may not be touched, but it seems short-sighted to think there won’t be any changes. And that could start at the top with Commissioner Hamburg.

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Adulterated Foods/Counterfeit Drugs: Punishment Should Fit the Crime

November 29th, 2012

We should all be grateful for the considerable protection we receive from FDA against unsafe food, drugs, devices and other products. This is FDA Matters’ belated but heartfelt Thanksgiving message. Thank you, FDA.

What FDA cannot do alone—and for which we as a society need to step in—is to change the laissez-faire attitude, laws and enforcement affecting intentional contamination and counterfeiting of FDA-regulated products. When Americans die from intentionally tainted milk, counterfeit products or negligently compounded drugs, we need to recognize this as murder. Let’s step treating it as if it were white-collar crime.

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“Governing,” Not “Campaigning,” Key to Post-Election FDA

November 5th, 2012

Since last week’s two columns on “FDA After the Election,” FDA Matters has been treated to some wild speculation about what will happen next. I have been told, in effect, that “if Obama is re-elected, there will be massive new industry regulation” and also that “if Romney is elected, FDA will be transformed into a non-entity that only says ‘yes’ to industry.”

What history tells us is different: whoever wins will have the burden of governing. As a result, massive new regulation is no more likely than FDA becoming a toothless regulatory agency. Winners, it turns out, spend a lot of time explaining why campaign promises haven’t been translated into action.

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FDA After the Election—Part 2: Leadership and Change

October 30th, 2012

Apart from an occasional reference, FDA is not part of the campaign dialogue leading up to the November 6 nationwide U.S. election. Yet, FDA Matters believes that FDA will be strongly impacted by the election’s outcomes. Part 1 of “FDA After the Election” concentrated on the agency’s budget situation.

Part 2 of “FDA After the Election” focuses on leadership and change–directly and as they may be affected by potentially large budget cuts. There are some predictable elements, but other elements with great impact may depend upon the perspective of those in power for the next two years and beyond.

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FDA After the Election—Part 1: Budget

October 29th, 2012

Apart from an occasional reference, FDA is not part of the campaign dialogue leading up to the November 6 nationwide U.S. election. FDA Matters believes this is probably good—any intelligent discussion of FDA’s future requires a long-term perspective and a mastery of detail and nuance—both of which are in short supply during “sound bite”-oriented politicking.

Yet, FDA will be strongly impacted by the election’s outcomes. Part 1 of “FDA After the Election” concentrates on the agency’s budget situation, while Part 2 focuses on leadership and change.

Both parts reflect that ultimately FDA is people-driven—not only by who leads, but also because over 80% of the agency’s costs are people-related. More money = more people = more capability and activity. Less money will have the opposite effect.

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Drug Product Pricing 101: A Fundamental Issue Revisited

September 7th, 2012

Eighteen months ago, FDA Matters wrote about the firestorm created by KV Pharmaceuticals’ decision to “charge $1500 per dose for Makena, a drug that reduces the risk of pre-term delivery in pregnant women. The same therapy has been compounded in pharmacies for years at a cost of $10 to $30 per dose.”

Three months ago, K-V Pharmaceuticals filed for bankruptcy protection. This week, a federal judge rejected the company’s last-ditch effort to save itself by ruling that FDA had discretion to permit continued compounding of the drug.

No one knows the “right price” for this or any other drug, but there are ways to rationally evaluate and guide product pricing decisions. Apparently, not everyone in industry knows this.

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FDA and the Republican Platform: Harsh Words, Unclear Intent

September 3rd, 2012

Between “the FDA today” and the “FDA in 2013” stands a U.S. presidential election—one that appears to offer Americans a choice of philosophy about the size of government and the role of regulatory agencies. FDA Matters’ previous blog laid out some very early comparisons between the candidates on regulatory policy and the role of Commissioner.

Along with nominating Mitt Romney as its Presidential candidate, this past week’s Republican Party convention produced the party’s 2012 Platform –a series of policy positions to guide the campaign. FDA reform commands about 180 words—laying out the case for aggressive (although unspecified) changes.

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Why Orphan Drugs are a Key Part of Pharma’s Future

August 23rd, 2012

I was recently interviewed about orphan drugs for the British website “pharmaphorum” and thought my readers might be interested. Here is a sample:

HB: How has the orphan drug space changed since the introduction of the Orphan Drug Act 1983?
SG: There is really no way to compare the situation. When we passed the Act, we hoped to stimulate the development of a few drugs that would make a difference in people’s lives. No one foresaw that we were creating what would become a multi-billion dollar market segment in which companies might compete fiercely to be first. The timing was also fortuitous — in that the Act was adopted just as our capabilities in biotechnology began to grow and the two movements are closely intertwined.

Click on the heading for a link to the full interview.

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FDA and the 2012 U.S. Presidential Election

August 1st, 2012

FDA Matters has been wondering: when is the right time to start talking about the 2012 U.S. Presidential election and how it might affect FDA’s future? The best answer is: when Congress has finished its FDA policy work for the year. With the enactment of FDA user fee reauthorization legislation and a pending agreement on government funding for the first half of FY 2013 (starts October 1, 2012), it is now time to start talking.

Without picking sides: what issues face FDA after the election and in 2013? How might the agency be affected by whether President Barack Obama is given another four year term or challenger Mitt Romney is elected President?

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FDA’s E-Mail Scandal: First Impressions

July 23rd, 2012

According to the New York Times, FDA collected more than 75,000 employee e-mails in an effort to identify leaks of confidential trade secret information. At some point, a narrow, possibly legitimate inquiry into a handful of scientists at the Center for Devices and Radiological Health (CDRH) turned into a massive e-mail surveillance of selected individuals and their contacts.

So far, FDA is not contrite. FDA’s position, while still not quite official, appears to be: we tried to accommodate these individuals’ complaints within the personnel and dispute resolution systems. We had legitimate concerns that trade secrets were leaving FDA in their correspondence with third parties.

FDA Matters believes we don’t know the whole story yet.

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