There’s a new contributor today on THCB. Blunter worked at the FDA for many, many years and understands from the inside many of the problems with the agency that have been documented in many places, such as this Forbes article. He responded to my notion that the problem is simply the speed of the drug approval process and suggests that the issues go way deeper. What he says about the management of the agency, the culture of secrecy and the information obfuscation is well worth taking seriously:

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There’s a new contributor today on THCB. Blunter worked at the FDA for many, many years and understands from the inside many of the problems with the agency that have been documented in many places, such as this Forbes article. He responded to my notion that the problem is simply the speed of the drug approval process and suggests that the issues go way deeper. What he says about the management of the agency, the culture of secrecy and the information obfuscation is well worth taking seriously:

You and those following the travails of the Food and Drug Administration (FDA) are on the wrong track if your views of the FDA problems are focused on the rate of drug approvals and postmarketing reports. When it is finally revealed that gutless FDA executives sold User Fees as a solution (politically naive) instead of addressing the real management and public policy issues, the crux of the present problem is clarified. There is nothing inherently wicked about user fees but the original and subsequent managers didn’t press the other fundiing and management needs

Within a year of the first user fee enactment (about 12 years ago), FDA was meeting the new deadlines without hiring or training any new MD’s. And a whole reserve of physicians receiving premium pay and scientists are secreted away in the FDA halls in "non-traditional" endeavors—mainly management—often beyond their expertise and capabilities. Examples abound where FDA top execs are ignorant of basic management responsibilities and skills in themselves and their subordinates, beginning at the Commissioner’s Office.

Look at EPA, NASA, NHTSA (and its potential model NTSB) and compare basic budgets to that of FDA which regulates vastly more of the GDP. What regulatee would object to paying a few million dollars to get a statutory deadline and perhaps as little as an additional week or two of sales. Just divide $1 or $8 billion by 365 to see the daily return. And the user fee concept is spreading to devices, animal drugs, food, cosmetics.

FDA seeks an analysis and report by the National Academy of Science or other prestigious group as a CYA tactic. There are lots of similar reports lying around comatose from past misadventures. However, the tactic permits FDA and other Administration folks to say it is inappropriate to discuss specifics of the latest debacle(s) before receipt of the blue ribbon report. Hence, we have FDA on autopilot until the dust and fervor clears and a new executive crew gets in that can say that "it wasn’t on our watch".

This present controversy and period may end up as little more than a footnoted historic anecdote in the next report of the next FDA crises a few years hence. The answer involves leadership with a new and skilled management team, to make the FDA a safe and effective environment for FDA scientists (among the best) to do their best work, create a transparency in the work FDA does, and cause the Congress to accept responsibility for funding a mission that has no peer in the Federal government. For sure, more funding which would be effectively applied will be needed but unlikely to do much good so long as the current management and culture is allowed to continue.

Presently, outsiders who want or need information on FDA decisions, and the like, are channeled through a Freedom of Information process which takes two years or more just to get around to the request, and then some more time and redactions to get the info out, if indeed any is released. It has been a long-standing, recognized management incompetence, worse in the Center for Drug Regulation than anywhere else (probably in the whole government). There is no transparency in what FDA is acting on, or ability for any one to compare in real time other similar data by scientists or others, who may have data of their own or seek to learn from the existing records FDA has passed upon. And when it comes to other than medical and scientific data, the likelihood of getting anything at all to look at several years down the road is even more remote.

And there has been no effort in the last near decade to do anything about it, like introduce management or data submission processes to make the system workable. Human clinical data and drug experience (appropriately clad to protect patient privacy) is a public resource, not a trade secret, for example. But you’d never know it at FDA.

Ironically, the FDA cannot be suspended on life support while a solution is devised or changes made. But there is hope. Under Jimmy Carter, the prevailing view was the Presidency had grown too complex and demanding for one person, and the talk was how to divide it. Then came along Ronald Reagan, The Bushes, and Clinton, and those discussions are footnotes on history. What can an effective and motivated leader do? A lot. Still don’t believe that FDA’s lack of leadership isnn’t just an issue but the issue. Look at the Forbes Magazine story and survey (mentioned on one of your earlier blogs) and see that the need for leadership at FDA outranks the closest competitor by three times or more.

A quick trawl of the blogs this morning finds me catching up on an excellent article on the present and future of DTC from John Mack at the Pharma Marketing Blog, and discovering a new anti-pharma blog called Pharmopoly. Obviously take this with a pinch of salt but here is what the anti-globalization folks at Pharmopoly are saying, and note that drug companies are now moving squrely into their cross-hairs over patnets and reimportation as well as over thrid world imports:

Global Growth launched the Pharmopoly campaign in mid-2004 as a response to Big Pharma’s concerted worldwide lobbying for protectionist laws benefiting their profits at the expense of the sick and the poor. Last year saw an unprecedented, Big Pharma financed, multi-million dollar political lobbying and advertising effort. The lobbying was aimed at influencing the outcome of the U.S. elections in the direction of Big Pharma’s preferred candidates and creating a political climate favourable to their interests globally. That lobbying effort earned Big Pharma a huge legislative payback. High prices for drugs result from the ability of the pharmaceutical monopolies to manipulate patent laws, trade treaties and legislation in order to deter competition. Big Pharma also buys political influence with the specific aim of boosting tax-financed prescription payment subsidies on a gargantuan scale. Only the arms industry relies on taxpayers for its profits more than the pharmaceutical industry. In the developing world already high prices are further compounded by costly import tariffs and ‘luxury’ taxes on foreign manufactured pharmaceutical treatments.

So the sick in rich and poor nations alike face twin threats from revenue hungry governments and corporations seeking to exploit patient necessity – despite the dying having no choice but to obtain drugs at whatever price they can afford. The Pharmopoly campaign aims to expose the high costs to patients of protectionism, import tariffs and government granted patent monopolies.

The Pharmopoly campaign’s three objectives are; firstly to promote the tariff-free trade of drugs in the developing world, secondly defend the parallel trading of pharmaceuticals in the rich industrialised nations. Thirdly, to lobby legislators for patient-friendly duration limits on government granted monopolies which will reduce the long-term costs of drugs for patients. We are campaigning for safe, free and fair trade in drugs worldwide.

UPDATE: Paul Staines from Pharmopoly writes: Thanks for referencing our Pharmopoly blog, but just one point; we’re not “anti-globalization folks”, we are pro-free trade, pro-free enterprise. We’re not against Pharma making a profit. We’re against the abuse of monopoly powers granted by patents and the political influence Pharma has over politicians, particularly in the United States. Big Pharma is arguably against free trade and for protectionism whilst deriving its profits increasingly from socialised medicine. Third world governments are also in our “cross-hairs” – for putting excessively high tariffs and luxury taxes on imported medicines. We’re in favour of free trade in pharmaceuticals across borders.