Asked this morning about the qualities needed in the next FDA commissioner, Sen. Charles Grassley (R-IA) called for “somebody outside of FDA and with no ties to the pharmaceutical industry.”

Speaking at the annual Families USA conference in Washington D.C., Mr. Grassley said when his investigations reveal a problem with a drug, he often hears from pharma executives who ask to come and talk it over.

“There’s only one person who should be across the table from the FDA,” Grassley said, “and that’s John Q. Public.”

The Senator, who has long exercised his oversight responsibility for the FDA, lambasted the agency for having a culture of “go along to get along.” He called for post-market surveillance functions at FDA to be removed from the Office of New Drugs.

Mr. Grassley, of course, is also the principal cosponsor of the Physician Payments Sunshine Act, which we support.

A flurry of medical organizations have announced their own disclosure policies following the reintroduction of the Physician Payments Sunshine Act last week.

The Star-Tribune reports that Park Nicollet, a large Minnesota health provider network joins the Cleveland Clinic as one of a few private providers disclosing payments to its doctors on a public website, and the North American Spine Society will now require all its members involved in Society activities to disclose their industry payments, as well, says the Wall Street Journal.

The New York Times reports that Smith & Nephew medical device company is asking its reps to keep it 9-to-5 with doctors at the upcoming American Academy of Orthopedic Surgeons conference, happening in that oh-so-9-to-5 town, Las Vegas. And after some after-hours allegations of a 2002 Medtronic whistleblower settlement were leaked last year, it’s easy to see why.

All this suggests that if there’s a transparency tide, it seems to be turning. And that’s good. Voluntary disclosure is good – but as we’ve argued here before, it does not reduce the need for the Sunshine Act, which would provide patients with a comprehensive, uniform, and reliable one-stop resource on doctors’ relationships with drug companies.

“And those of us who manage the public’s dollars will be held to account — to spend wisely, reform bad habits, and do our business in the light of day —”

That call to transparency President Barack Obama issued in his inaugural address Tuesday seems to be answered, at least in part, by the reintroduction of the Physician Payments Sunshine Act today. The bill, co-sponsored by Sens. Charles Grassley (R-IA) and Herb Kohl (D-WI) would require prescription drug, medical device, biotech companies and their subsidiaries to disclose all payments that add up to more than $100 into a national and publicly accessible online database. It would capture not only small gifts, meals and conference payments, but the big-ticket consulting, advisory payments and honoraria that have landed some physicians in the hot seat and the headlines lately.

It’s a strong bill, and we are excited to see gathering support for it from editorial boards and industry bloggers alike.

This two-part series in the Milwaukee Journal-Sentinel last week is a great case study in why a Sunshine law is important – it highlights some of the problems with the current patchwork system of self-reporting at some medical centers, which Robert Steinbrook eloquently lays out in this week’s New England Journal of Medicine.

“At present,” Steinbrook writes, “physicians and researchers often report industry payments confidentially to their medical school or medical center. Such reporting, however, may be voluntary and may not be subject to verification. There are wide variations in the level of detail, reporting procedures, and stringency of institutional policies and oversight. The information may be actively reviewed or merely collected.” He looks at the move of a few medical centers to make that information public online, and the prospect of the federal bill.

In FDA news, In Vivo blog wonders whether it’s Dr. Joshua Sharfstein for commissioner as the new administration looks closer to tapping someone to lead the FDA.

And Dr. Steve Nissen, one of those on the short list, is one of six scientists who penned public letters to the new President in Nature journal.

“Secrecy is antithetical to both science and good government, but much of what the FDA knows about drugs, it never publicly discloses,” Nissen writes, and says that secrecy is one of the reasons many consider the FDA “a failed agency”. “The Obama administration has the opportunity to reinvigorate the FDA, but only through major restructuring and policy changes that are designed to protect the agency from undue influence, and to promote transparency,” Nissen wrote.

The Bureau of National Affairs Health Care Daily Report (subscription required) has the roundest of all round-ups on what Congress plans to do on pharmaceuticals this session (including outtakes from our conference keynote speaker Rep. Henry Waxman.) Drug safety, marketing, off-label usage, biogenerics and reimportation: it’s all here.

The growing proportion of pharmaceutical ingredients made at uninspected overseas plants, particularly China, concerns those that think about U.S. drug supply and stockpiling efforts, according to the New York Times.

And we’ll close with another beginning: Eye on the FDA has a good post about FDA Acting Commissioner Frank Torti’s version of an inaugural address, which you can read or listen to here.

Acknowledging the ‘acting’ part of his title makes the job even tougher, Torti addresses consumers, Congress, academics, and industry, to which he offers this pledge: “We promise you that our deliberations will be completed with respect, diligence and speed, but always remembering the old, but wise admonition of Hippocrates, to first do no harm.”

While some folks in Washington are picking out their finest for the Inaugural Ball next week, officials at the FDA are putting on their PR flak jackets and wielding their rule-making pens.

There’s no shortage in the supply of FDA news in the final days of the Bush administration, which presided over what many view as a disastrous chapter in the history of the agency: a record number of post–market safety problems, including Vioxx, Avandia, and Paxil, the heparin crisis, chronic underfunding, declining approvals, an under-inspected supply chain, internal strife and suppression of science, and revelations that clinical trials for approved drugs have been massaged, ghostwritten, and conflated, or just plain withheld to promote sales.

As a TV drama, this final flurry of bad news and fast moves obeys all the rules of a good season finale. As a public health agency, it just spells trouble.

Episode 1: On Monday, a report by the Inspector General of Health and Human Services found that the FDA does little if anything to monitor conflicts of interest among clinical trial investigators. The agency requires drug and device companies to submit with its clinical trials forms disclosing any conflicts of interest that investigators running those trials may have. But according to the New York Times, “the agency did not receive forms disclosing doctors’ financial conflicts and did nothing about the problem” in 42 percent of clinical trials, and of those forms submitted, FDA officials didn’t look at them a third of the time.

In a year when conflict of interest investigations in medicine have turned up millions of undisclosed dollars in industry pay and evidence has surfaced that clinical trials have been designed, manipulated, or halted at the behest of pharmaceutical marketing departments, it seems nothing short of careless for the agency not even to be looking. Or, as the New York Times editorial board put it, “lame.”

Episode 2: Despite vocal concern from consumer advocates (us included), the FDA finalized an earlier guidance and enacted eleventh-hour rules that will allow pharmaceutical reps to distribute journal articles on off-label indications, though marketing and promoting for unapproved uses is illegal. In the guidance, the FDA says it doesn’t have the authority to require the companies to do clinical trials on such off-label indications, and that companies are no longer required to submit such articles to the FDA for approval.

By not requiring either of these, Peter Lurie of the Public Citizen Health Research Group told the BNA that FDA has removed any incentives for companies to test and prove the indications through well-designed trials.

“Right now, there’s a bright line that distinguishes the on-label from the off-label use,” Lurie said. “But that line is erased by this, and it will create confusion in the minds of the doctors, and ultimately they will begin to equate the evidence that supports the on-label from the off-label, and that is not justified.”

Physicians who see drug reps: be prepared to be flooded with reprints from journals you’ve never heard of.

Episode 3: Last week, nine top level FDA scientists wrote to HHS Secretary-appointee Tom Daschle, confirming the systemic mismanagement and acrimony we’ve been hearing about for awhile now. The authors have no shortage of examples on how their work was derailed by agency politics, but this line stood out: “Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,” the letter said.

This Financial Times editorial calls on the incoming administration to make fixing and funding the FDA a priority, and offers its European counterpart as a case study. “The European Medicines Agency has moved more swiftly than the FDA in approving some new medicines, establishing principles for generic biological drugs and fostering partnerships with commercial and academic researchers to rethink regulation,” the Times wrote.

Season Cliffhanger:  On Monday, the HHS transition team named Dr. Frank Torti, an oncologist who joined the FDA last April as chief scientist, to be acting director until a permanent commissioner is found. Speculation on who that might be continues, though you may remember some FDA watchers on the Hill had asked the incoming Obama administration not to name an acting or permanent commissioner from within the current agency.

How else could we end this post? Stay tuned…

With the change of the calendar year, Big Pharma has rolled out its New Year’s resolutions like the rest of us, most prominently the revised PhRMA  voluntary code of conduct, which aims to stop the trinketeering, lavish meals, and travel payments to prescribers.  The code changes, combined with pledges by some drug companies last year to disclose payments to physicians have got some observers (including reporters) saying that maybe the industry has turned a new leaf.

Maybe. But let’s look at what the companies have really said:

In September 2008, Eli Lilly, which already discloses its educational and charitable grants on its website, said it would begin to publicly report all speaker and advisory payments by the last half of 2009, and in 2011 would make public all payments to docs over $500 (including meals, entertainment, and travel).

That same month, Merck announced it will report all speaker payments in 2009. No sign of that yet (according to our very recent internet search).

In October, GlaxoSmithKline, under fire from a Senate investigation into Dr. Charles Nemeroff’s busy and lucrative speaking schedule, announced it would disclose payments to doctors and cap payments per doctor at $150,000 a year (nice work if you can get it), but has not given anymore specifics, like where, or when, or what kind of payments.

The Project praised these commitments at the time, and we’re still happy to see companies taking (or planning) steps toward great transparency. But let’s remember that information transparency only as good as the accessibility of that information– meaning, can people get to it, and understand it once they do?

We think that each drug company disclosing the payments it wants, starting when it wants, in a format of its own choosing is a bad deal for patients – who are the reason transparency is so important.  The unbiased clinical decisions clouded or threatened by these corporate relationships are, after all, decisions about them, and their health.

Patients should not have to go to seventeen different websites to see whether their doctors are taking funds from drug companies, which is why a single, uniform and publicly accessible database like the one proposed in the Physician Payments Sunshine Act makes so much sense.

to Ed Silverman, reporter-king of the Pharmalot blog, who signed off today after two years writing the heard-it-here-first pharma industry blog.  Even though Pharmalot, Ed’s own invention and masterwork, was an exemplar of how the news business could adapt and thrive in the Web Age, the blog was still tied financially to the traditional, tanking newspaper business – and if we’d known, we would have personally taken out a whole lot more classified ads in the Star-Ledger than we did.

Thanks Ed – you’ve been an irreplaceable resource for information, perspective, and wit, and we’ll all be scrambling to pick up the slack left in the pharma-rope.

To read our interview with Ed after Pharmalot’s first birthday, go here.

And for his very own goodbye: