It’s been 927 days (back of our envelope, anyways) since Senators Charles Grassley and Herb Kohl first introduced the Physician Payments Sunshine Act, a bill that would require drug and device companies to disclose on a public, searchable website the gifts and payments they make to physicians and teaching hospitals. (Postscript is younger by a few weeks.)

Today, the Sunshine Act became law, as a provision in the national health care reform bill signed by President Obama. You can read the final provisions here.

Though it has not captured headlines like the coverage provisions and insurance regulations in the reform bill have, today’s passage of the Sunshine act is itself a dramatic answer to years of growing questions about how to balance the need for industry to work with academic researchers and the need to keep patients safe with good prescribing that is free from the influence of marketing. In recent years, that line has often proved a blurry one, as a series of investigations and media reports revealed that physicians have received millions of undisclosed dollars in speaking and advisory roles for drug companies, even as they conducted research on drugs made by those companies. PostScript has been along for much of that ride (as the archives in the right rail attest).

The momentum for Sunshine has come from a lot of corners – the investigations and hearings, led by Sens. Kohl and Grassley, that brought to light some of the most dramatic conflicts-of-interest between marketing and medicine.

It has come from many Members of Congress, who co-sponsored, worked on and advocated for Sunshine over the years.

It has come from academic medical centers and professional medical associations, who took a look at their own relationships with industry and developed policies to clarify those relationships.

It has come from the AMSA Scorecard, a joint project of the American Medical Student Association, Community Catalyst and the Pew Prescription Project  to rank the conflict-of-interest policies at every medical school in the nation.

It has come from state lawmakers and regulators, who brought bills and rules aimed to better safeguard prescribing from the influence of marketing dollars.

It has come from the efforts of numerous groups, including ours here at Community Catalyst and at the Pew Prescription Project.

It has come from the broad-based National Coalition for Appropriate Prescribing, which helped remind Congress why transparency is so important for consumers.

And it has come from pharmaceutical and medical device companies, many of whom acknowledged, in revised conduct codes and voluntary disclosure measures, that gifts don’t have a place in the doctor’s office.

We are proud of this collective effort, and all the work that went into getting Sunshine on the books. Thank you.

–Kate Petersen, PostScript blogger

The astonishing theft of $75 million worth of antidepressants and other drugs through the roof of an Eli Lilly distribution warehouse in Connecticut earlier this week is just the latest and most acrobatic incident in a rash of prescription drug theft, and highlights the importance of establishing better tracking of drugs in the pharmaceutical supply chain. According to Freightwatch, a group that tracks cargo security, reported drug theft has quadrupled in the last four years. Last year, nearly $200 million worth of prescription drugs were stolen in the U.S. There were five pharma thefts in the month of February alone.

The case highlights the need for a start-to-finish, tamper-proof drug pedigree on every prescription drug that’s sold. As the Secure Pharma Supply Chain blog wrote, “the issue of pharmaceutical cargo theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.”

Right now, prescription drugs that go missing (through the roof or otherwise) are often exempt from having a pedigree once they reach a hospital or pharmacy because of regulatory gaps. Under current federal and state regulations, many parties are excluded from pedigree requirements – authorized distributors, for one—so a drug’s paper trail ends once it passes through their hands. Stolen drugs, which may be improperly stored or tampered with, can be sold back to authorized distributors, and pharmacies and hospitals that buy from them have no way of knowing of the risks.

Another problem is that it’s a paper trail—papers can be easily swapped forged or lost.  And the documents that are required are for whole lots of drugs, making them meaningless in issues of partial-lot theft and resale we’ve seen occur (like the insulin units stolen from North Carolina cargo truck and found on Texas shelves months later.)

One solution would be to require an e-pedigree, an electronic barcode or radio tag on every bottle or package of prescription drugs, making it possible to track each stop along the supply chain from the factory to the medicine cabinet.  California is the only state to have an e-pedigree requirement, but implementation of that law has been delayed till 2015. A federal e-pedigree law has been proposed by Representatives Buyer and Matheson, and would be a more sensible solution for a globalized and interstate industry.

–Kate Petersen, PostScript blogger

Yesterday, the House Energy and Commerce Subcommittee on Health heard from FDA Deputy Commissioner Joshua Sharfstein on the safety of the drug supply and current agency practices to ensure the safety of marketed drugs.

Sharfstein, who has been a strong advocate for drug safety, both at the agency and previously  as health commissioner in Baltimore, made a forceful case for what FDA needs to keep drugs safe: “FDA needs additional tools to move our oversight capabilities into the 21st century.  FDA needs to access regulatory information quickly, hold all parties responsible for the quality of products in the supply chain, and have reasonable and reliable options for enforcement,” he said.

The hearing was notable for the bipartisan consensus that securing the safety of the drug supply is a national priority with high stakes, and unanimous agreement that the FDA’s ability to ensure that safety must be shored up. It convincingly framed drug safety as an equally urgent next step to a food safety measure that passed the House by a wide margin last year.

But perhaps the hearing’s most compelling arguments for a safer drug supply came in this stage-worthy exchange between Sharfstein (JS) and Chairman Emeritus John Dingell (JD), who has worked to support the agency’s drug safety efforts for much of his recent career.

JD: Dr. Sharfstein, I want you to understand these are friendly questions. I want yes or no answers. You are familiar with the heparin crisis, which caused 81 American deaths. Does FDA currently have the adequate resources, personnel, and authorities to prevent another heparin crisis?

JS: No.

JD: Do you have the ability to control the safety of imported pharmaceuticals?

JS: Not to the extent we’d like.

JD: Do you have the authority and resources to address the safety of components being now imported into this country?

JS: No, not to the extent we’d like.

JD: Do you have authorities and resources to see to it that good manufacturing practices (GMPs) are properly observed overseas?

JS: Not to the extent we’d like.

JD: Would you please submit to the committee the number of people that you have at the different ports to ensure the safety and the inspection of pharmaceuticals coming into this country, and also would you give the number you need to see that this is done. Please submit that for the record.

[JS assents]

JD: Do you have adequate authority to keep out unsafe drug shipments at the border?

JS: No.

JD: Do you have authority to require manufacturers to ensure the safety of their supply chain?

JS: No.

JD: Do you have the authority to see to it that GMP are observed in this country on both food and drugs, and abroad? Yes or no?

JS: No, not to the extent we’d like.

…
JD : Do you have adequate authority to require mandatory drug recalls?

JS: No.

JD: Do you need that authority?

JS: We would like it that authority, yes.

JD: Would you like it or do you need it?

JS: I’d say we need it.

JD: [refers to the Food and Drug Administration Globalization Act of 2009 and its cosponsors] [FDAGA] would give you significant authorities to address your current lack of capabilities?

JS: That legislation has very important elements, yes.

JD: It would also give you the [financial resources] you need by enabling you to collect fees from both manufacturers of food and pharmaceuticals? Is that right?

JS: It does have that provision, yes.

JD: And you can do that both at home and abroad, is that right?

JS: I believe so, yes.

JD: Are those resources and fees included in your budget submissions to the Congress?

…

JS: For food it is.

JD: How about pharmaceuticals?

JS: I don’t believe so, no.

JD: Now it’s a curious situation I’ve observed, that you are in the awkward place at FDA of having somebody be able to bring unsafe foods into the United States, and you can’t catch them at the point of entry. But you also have the problem that if you do catch them, you don’t have authority to seize, impound or to destroy. Is that right?

JS: Yes.

JD: So you send them back out?

JS: I believe so. Often that’s what happens.

JD: And they then often bring them back in, through another point of entry?

JS: I think they can try, yes.

JD: Do you have that same problem with pharmaceuticals?

JS: Yes.

JD: So that problem exists in both places. So you have problems with unsafe commodities being brought in—foods and pharmaceuticals. You also have some that are over-aged, improperly stored, contaminated, filthy, improperly packaged. Counterfeit. And you also have some that are full of inert substances, you mentioned talcum powder…Do you have authority to deal with those?

JS: We have some authorities. But not–

JD [interrupts] Do you have enough?

JS: We don’t have enough.

JD: As proven by heparin.

JS: Yes, in part.

JD: And you have coming into this country from China on a fairly regular basis—and from Mexico and other places—unsafe food and pharmaceuticals. I can recall mushrooms. I can recall berries. I can recall tomatoes and jalapeno peppers. I can recall the heparin scare. And a large number of others. This is an ongoing and continuous problem, is it not?

JS: Absolutely.

JD: And you lack the Congressional support, both in authority and money, to do the job that you need to do to protect the American people? Isn’t that right?

JS: Well, we very much want to do more.

JD: I don’t want you to be afraid to say that we haven’t given you  the authority you need—

JS:  No we want more authority—

JD: —If it’s the truth, because we’re going to try to get it for you.

–Kate Petersen, PostScript blogger

Sneak preview: This afternoon, the House Energy and Commerce subcommittee on Health will hear from FDA Deputy Commissioner Joshua Sharfstein and other agency officials at the first drug safety hearing since the new administration took office. We’ll have more on what Commissioner Sharfstein has to say later this afternoon.

In other FDA buzz,  Mark Senak at Eye on FDA says that shifts in web referral traffic–Facebook now tops Google as the top referring site—underscores the power shift toward social media on the web:

The emergence of Facebook as a driver of traffic signals an important shift in the way that people are getting and consuming information.  More than ever, the idea of referral from a contact is taking up a huge proportion of the spectrum.  That means that for any message – whether it is product related, or public health related – to gain traction, you have to do more than build a Web site and wait for people to discover it.  You have to have a Facebook presence.

Mr. Senak, who consults industry on communications, points to some of the problems of a regulated industry participating in a space as splintered and unregulated as Facebook and Twitter, when it’s not always clear who’s doing the talking. He says FDA should be on Facebook. But it’s not clear exactly what he wants the agency to do once it gets there – serve in an ombudsman or watchdog role? or actively engage with consumers and those in the pharma community? Just avert the “Risk of Ignoring”? In a previous post, he suggests that Facebook would provide a good portal to agency resources, and that may be so, but he leaves aside the important question of how the FDA might protect public health in that space.

This is part of a larger conversation about how pharma and medical device companies operate on the internet – an act which, we note, is a form of marketing. The FDA is charged with regulating the marketing of approved prescription drugs and devices.

In November, the agency invited the public to weigh in on how the agency can uphold its mission to protect the public health as companies move more and more of their marketing resources and attentions to the internet. Community Catalyst and the Pew Prescription Project urged FDA to proceed with caution—and until there is good evidence of public health benefits and comprehension of risks in online venues, existing rules about how companies talk to consumers and what they say should not be bent or relaxed.

But Senak detracts from his call for FDA to “be there” by urging companies not to wait for rules or guidance, suggesting that those who wait to understand the parameters of online marketing do so at their peril.

And so as FDA slowly grapples with its increasingly complex task of developing some guidance around social media – an environment that is constantly evolving at breakneck speed – the agency needs to consider how people are in fact communicating today and companies need to decide if they can afford to wait for the agency to issue any parameters for operating in this environment or they forge ahead and hope for the best.  At this point, you must decide if you shape the environment, or you let it shape you.

It’s a worrying rallying cry, considering that these companies aren’t selling refrigerators – they’re selling life-changing and lethal substances.

–Kate Petersen, PostScript blogger