On Friday, four House members introduced important drug safety legislation aimed to better protect the drug supply through tightened import rules, inspection, tracking, and FDA resources.

The Drug Safety Enhancement Act builds off the FDA Globalization Act introduced last year, and sponsoring Reps. John Dingell, Henry Waxman, and Frank Pallone have pledged to work quickly in the next Congress to pass the bill.

Here’s what the bill does, according to Friday’s statement:

• Creates an up-to-date registry of all drug facilities—both foreign and domestic—serving American consumers;
• Generates funding for increased Good Manufacturing Practices (GMP) inspections for brand and generic drugs;
• Requires parity between foreign and domestic inspections;
• Prohibits entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections;
• Prohibits the entry of drugs into the U.S. lacking documentation of safety;
• Requires manufacturers to know their supply chain, identify and mitigate risk throughout their supply chain, and to document measures taken to secure their supply chain;
• Prohibits false or misleading reports to FDA;
• Provides strong new enforcement tools, including mandatory recall authority, increased civil and criminal penalties, and new FDA authority to subpoena records related to possible violations;
• Provides protection for whistleblowers that bring attention to important safety information; and
• Requires unique identification numbers for drug establishments and importers to improve the ability of the FDA to more quickly identify parties involved in a crisis situation.

In a show of cross-cameral support, Senate HELP Chairman Tom Harkin and Committee member Michael Bennet immediately pledged to work with the House members on this drug safety legislation in the next Congress. Sen. Bennet, remember, introduced the Drug Safety and Accountability Act in August, which would improve manufacturing standards and give the FDA recall authority to pull drugs it considers unsafe off the market.

Why drug safety now? For those regular readers of PostScript, you know our take: a rising and record number of drug recalls last year, a borderless and increasingly splintered supply chain in which manufacturers may not know where their raw materials originated, much less how safe they are, and a semi-regulated global marketplace in which many players cut corners on quality control has injected a little too much guesswork into knowing how safe and effective our drugs are. The FDA has made big strides in the last several years to tighten up gaps in the supply chain, and the bill proposed last week would help the agency and industry go further.

For updates on drug safety legislation and news, follow SafeRxWatch on Twitter.

For summaries of previous drug safety legislation, a consumer survey on drug safety, and other resources, visit the Pew Prescription Project’s Securing a Safe Drug Supply.

–Kate Petersen, PostScript blogger

The 2010 American Medical Student Association (AMSA) Scorecard is out today, and for the first time since the student group began assessing conflict-of-interest policies four years ago, one half of all U.S. medical schools received an A or B (78 out 152).

That’s up from approximately one in three schools last year, and just 20 percent in that range just two years ago, suggesting that we really are engaged in a nationwide project to figure out what the proper role of the industry in  medical education should be.

About one-fifth of medical schools improved their scores over last year, the same improvement rate as we saw in 2009 over the previous year’s Scorecard. We think that’s really good. Let’s remember that these are giant, slow-moving academic institutions – not exactly the hares of the system-change race. That makes such steady and significant shifts even more impressive.

As for “most improved” candidates for the we-wish-it-existed AMSA Scorecard Yearbook, Tufts University would have to be up there, moving from D to an A and to the top of the class this year among medical schools in Massachusetts, as would University of South Dakota Sanford School of Medicine and Des Moines College of Osteopathic Medicine, who also jumped from Ds to As in a year.

We should point out here that the room between A and B is somewhat complex. The scorecard is composed of 11 domains:
-acceptance of gifts and meals from industry;
-consulting relationships;
-speaking relationships;
-disclosure of financial conflicts;
-pharmaceutical samples;
-individuals with financial conflicts participating in university purchasing decisions;
-financial support for educational events (on- and off-campus);
-industry support for scholarships and trainee funds;
-access of industry sales personnel to medical school or hospital personnel;
-and inclusion of education about conflict of interest within the academic curriculum.

Each year, AMSA asks all medical schools, early and often, for their policies in each of these domains and then using methodology developed with the help of the Pew Prescription Project, independent blinded assessors evaluate the policy out of a possible three points.

The needle’s been harder to move in certain domains than in others.

Unsurprisingly, very few—10 percent of schools—got a perfect score on their on-campus continuing medical education policy. Drug company sponsorship of grand rounds and other on campus co-hosted educational activities is a big money maker for medical schools, and can give a company talk the imprimatur it craves. The Accreditation Council for Continuing Medical Education gets this, and its policy recommendations have lagged behind many rule-making bodies and medical groups on decoupling industry-physician marketing relationships.

More surprisingly, perhaps, even fewer schools – just two – got a perfect score on limiting access to sales reps. A score of “3″ on industry access, according to AMSA’s scorecard site, is given to policies in which “pharmaceutical and device representatives are not allowed to meet with faculty regardless of location, or are not permitted to market their products anywhere inside the medical center and associated clinics and offices. (Exceptions may be made for non-marketing purposes, such as training on devices or equipment.)”

Schools that limit faculty and student interaction with sales reps, or where sales reps can go, but do not ban them, received a 2.

Still, the fact that no more than two schools banned sales reps outright is surprising to us because:

A) allowing sales reps on campus seems like the easiest, clearest example of letting industry inappropriately infiltrate your medical school. It’s in the name: they are there to sell stuff. Cutting out sales reps doesn’t get into questions of patient access to drugs or doctor access to education programs.

B)There are just less of them than two years ago. The last half of this decade hasn’t been a good one for sales reps, as pharma companies with trickling pipelines have slashed traditional marketing budgets in favor of … well, doctor-to-doctor CME, for one, and online campaigns. It seems that this would make it even easier for schools to put together great policies to keep the sales reps at bay. Maybe people need pens more than we thought.

For more, visit the 2010 scorecard at http://amsascorecard.org or check out the Pew Prescription Project resources on marketing and conflicts of interest.

–Kate Petersen, PostScript blogger

An investigative outfit’s consolidation and analysis of payments that drug companies made to doctors has refocused attention on state efforts to shine light on the financial ties between doctors and drugmakers.

Currently three states—Minnesota, Massachusetts, and Vermont—require drug companies to disclose payments to prescribers and make some of that data public. While each of these states takes a different approach to collecting and making the payment data available to the public (more on that here), information from all three have been extremely valuable in demonstrating the dimensions and scope of these marketing relationships. And now a new value to the state data has emerged: demonstrating that pharma isn’t keeping very good track of who it’s been paying what.

The ProPublica report in Monday’s Minnesota Star Tribune and here online found a series of big discrepancies between what a company said it paid a doctor on its website and what it told the state of Minnesota it paid the same person. Right now, ProPublica can only crosscheck the seven companies that have posted payments on their own websites.

Big pharma has been caught off-guard again. Like the reports earlier this fall that hundreds of sanctioned doctors were still making cash on the side with speaking gigs, some companies seem not to know who they are paying what. Despite spending billions of dollars to develop and manufacture drugs, and spending other billions to market them to prescribers and armchair prescribers (i.e. consumers), the folks who brought you Lipitor, Effexor, Zyprexa and that one that will send this to your spam folder, don’t seem to know what they paid docs to give PowerPoint presentations.

The report also gave some doctors the opportunity to say strange things:

Dr. Randy Shapiro, one of the doctors whose take was under-reported to Minnesota told ProPublica that if anything, patients should want to see their physician among the speakers on these payment lists. “If their doctor is not on the list,” he said, “maybe they should look for a different doctor.”

That’s…an interesting take. We’re not aware of any links between participation on speakers bureaus and clinical excellence or bedside manner. Based on some earlier findings (we’re thinking of the Risperdal, Biederman, and all these folks) we’re not sure that would be our prescription. (In fact, based on the mounds of evidence about the influence of even small gifts, we tend to think finding a pharm-free physician or one who is engaged on clinical projects she’s happy to tell you about, and not just the PowerPoint circuit, is the way to go).

And the top-paid physician in Minnesota, Dr. Todd Hess, a pain specialist in St. Paul who made over $364,000 last year, told ProPublica that the media is unfairly lumping these educational talks with the old pharma ways.

“This is a mountain-molehill thing,” Hess told ProPublica. “I know the problems of the past. I know what pharma has done to change those. People just can’t get over the past.”

Maybe he knows something that we don’t know, but it might not be a problem of a press corps with a too-long memory. Recently, awkward chuckles went up through the pharma news sphere when word of Abbott’s celebratory pig roast for a Maryland doc who managed to implant 30 stents in one day showed up in a Senate Finance report.

That wasn’t back in the high-flying, anything-goes 90s depicted in the recent pharma-flick “Love and Other Drugs.” It was two years ago. Teachers are warned not to grade 30 papers in one day (and this blogger can vouch for that advice). We’re pretty sure, like the Senate Finance Committee, that 30 stent operations in a day is an even worse idea.

Despite what headlined docs and pharma spokespeople say, there is still a lot of money changing hands for things of questionable clinical value. The thing about the ProPublica data is: it’s current. The stories about hundreds of millions of dollars going to sanctioned docs, the Massachusetts reports that just came out–those payments are all from 2009-present. And now we see it isn’t being recorded very well. Maybe some of these companies really did believe no one would bother to look.

“If all the reports are true I’m outraged,” Maryland delegate and physician Dan Morhaim told the Baltimore Sun.

According to the Sun, “Maryland’s General Assembly has explored limiting financial relationships between doctors and drug or device makers, but no laws have come from it,” but Morhaim said ‘it’s a continuing topic of interest’ in the next legislative session.”

While there are real and beneficial relationships between academic medicine and industry, Pew Prescription Project Allan Coukell told a Memphis paper this week that “patients deserve to know if their doctors are receiving money from drug companies.”

And patients and state lawmakers are right to be concerned about what add up to significant financial exchanges between industry and doctors willing to pitch drugs to their colleagues. We wouldn’t be surprised to see more states explore ways to keep track of or limit the types of payments industry makes to doctors. Regardless, pharma should take this opportunity to get its house in order so everyone’s on the same—accurate—reporting page by the time Physician Payments Sunshine kicks in.

–Kate Petersen, PostScript blogger

Among the food that has been recalled for contamination risks since the 111th Congress convened:

-Eggs (500,000,000+)
-spinach
-peanuts/peanut butter
-pistachios
-tomatoes
-jalapenos
-70,000 lbs of cheese

Among contaminated or recalled drugs suspected of safety problems since the 111th convened:

-Heparin
-millions of Tylenol, Motrin, Benadryl bottles, child and adult formulations
-Lipitor
-Paxil
-Bactroban
-Tagamet
-Kytril
-IV antibiotics

This week, the Senate finally passed a food safety bill (the House passed a version this summer). The bill, if signed, will give FDA resources to inspect manufacturing plants and farms and give the agency authority to recall food it considers unsafe (right now, a company must initiate a recall voluntarily.) With a little red tape between here and the President’s desk, the bill is on the verge of making much-needed and overdue reform to the way we protect and oversee our increasingly globalized food sources.

Our drug supply faces the same need. Our drugs are increasingly made from materials from all over the world, and GAO reports suggest thousands of plants that potentially manufacture raw materials for prescription and over-the-counter drugs on American pharmacy shelves go uninspected each year. Right now, manufacturers aren’t held accountable enough for ensuring all those materials are safe.

This year saw a record number of drug recalls for Good Manufacturing Practice (GMP) violations, signaling the FDA is marshaling its resources well to step up vigilance. But it also suggests that there are big and perhaps growing quality problems plaguing the supply chain that manufacturers don’t have a handle on yet. Bills and a discussion draft before Congress now would give the FDA mandatory recall authority, as the agency will have now for food, and would establish more stringent supply chain management requirements for drug makers that regulators could use to better enforce drug quality and safety, both in the drug application and post-market phase.

The tools are there, and so is the urgency. We hope before this Congress adjourns that it moves to protect the drugs in American medicine cabinets the way it acted this week to protect the food on our tables.

For more on how to secure America’s drug supply, follow SafeRxWatch on twitter and Facebook, and visit Community Catalyst’s Prescription Access and Quality resources and the Pew Prescription Project.

–Kate Petersen, PostScript blogger

In the year after drugmakers removed over-the-counter cough and cold medications for infants and toddlers from shelves, emergency room visits for kids under age two linked to overdose and adverse events were halved. In a study in the current issue of Pediatrics, CDC researchers looked at the number of visits to a random sample of 63 emergency departments in the 14 months before and after the October 2007 market withdrawal of cough-and-cold meds for children under the age of 12. Though the information about the specific formulation of cough-and-cold med was not available in all cases and limits the conclusions about specific products, the findings are evidence that such a preventive public health campaign can have significant impact.

Meanwhile we are awaiting new FDA dosing guidelines this month for OTC pediatric cough and cold meds; the guidelines were due out this summer but were delayed.

Drugmakers pulled multi-symptom cough-and-cold meds for infants and toddlers in Oct. 2007 and more in 2008 after pressure from a citizen petition filed by then-Baltimore Health Commissioner Joshua Sharfstein and other pediatricians, demanding that the FDA visit the safety requirements and standards for over-the-counter (OTC) pediatric cough and cold medication. Such medications, marketed for children, are not subject to any required efficacy standards and have been linked to infant deaths.

The agency responded by recommending that children under 2 not be given OTC cough and cold meds and formally reviewing its standards. In 2008, makers of those products voluntarily changed labeling to suggest such drugs not be administered to children under 4. The rest of the story, as they say, is that Dr. Sharfstein was since named principal deputy commissioner at the FDA.

Pediatrician Andrew Racine told Healthday the concerns are the same today as they were when Sharfstein and others filed the petition:  “The efficacy studies for these things are not very robust, and the potential bad effects have been well-documented,” he said.

Although cough-and-cold meds constitute a relatively small portion of emergency room visits for children under age 12, the authors write, “the safety concerns they have raised demonstrate how public-private collaborative efforts and a combination of education, engineering, and enforcement strategies can be used to improve medication safety in the outpatient setting.”

–Kate Petersen, PostScript blogger

The safety and integrity of the global drug supply chain stands among the FDA’s major proposed priorities for the next four years. We support this plan wholeheartedly, as the challenges of globalization have far-outstripped the FDA’s resources for inspections and quality monitoring, and thus the risk to consumers has been growing. We have seen many supply chain malfunctions of late, from fungus in antibiotic IV bags from India, to bacteria in over-the-counter children’s medications from Pennsylvania, to the tragic deaths in 2007 and 2008 from contaminated heparin, a blood-thinner produced in a Chinese factory and administered to American patients.

Our position is pretty simple. We believe Americans have a right to uncontaminated medications. The prescription and over-the-counter drugs we rely on to keep us healthy should contain the correct amount of active ingredients as stated on the box, should not contain any contaminants, and should not have been adulterated at some stage of manufacturing. The solution is not as simple, but with commitment from manufacturers and with FDA oversight as a safeguard, we can provide safe drugs to those in need. Additional information on our work on drug safety, including legislation that would enhance the FDA’s oversight authority and resources, can be found on our website.

The FDA’s report said it would shift its focus to prevention – stopping threats before they ever become a reality. To do this, the FDA will require more information about all phases of production and distribution, along with regulatory standards that foster corporate responsibility; more coordination among foreign, federal, and state entities; updated enforcement tools; increased inspections; and updated systems including Information Technology.

Community Catalyst and six other organizations jointly submitted comments in support of the FDA’s proposal for strengthening the safety and security of the global supply chain. These groups include:

• The American College of Physicians
• The American Federation of State, County and Municipal Employees (AFSCME)
• The Bulk Pharmaceuticals Task Force
• Consumers Advancing Patient Safety
• Health Care for All (Massachusetts)
• Our Bodies Ourselves

Our comments explained the importance of improving the global supply chain from the perspective of consumers, health care providers, and drug component manufacturers. You can read the comments here.

Also offering comments in strong support of the FDA plan were:

• The Pew Health Group of the Pew Charitable Trusts
• Consumers Union, the non-profit publisher of Consumer Reports
• The American College of Cardiology

Some organizations asked that the FDA go further in certain areas. The Academy of Managed Care Pharmacy (AMCP) said it was especially concerned about increasing reports of counterfeit medications. The Biotechnology Industry Organization requested that the FDA adopt a uniform national standard for product pedigrees or track-and-trace technology to deter and combat counterfeiting and intentional adulteration. The National Association of Chain Drug Stores reported that many of its members are already taking action to strengthen the domestic drug distribution supply chain, such as supporting wholesale distributor licensure or requiring their wholesale distributors to purchase prescription drugs directly from manufacturers, to cut down on the possibility of counterfeit drugs being sold to pharmacies.

Overall it is impressive that comments in support of strengthening the safety and integrity of the global supply chain were submitted by a very diverse set of stakeholders. How often do health care providers, consumer advocates, unions, chemical manufacturers, and retailers advocate for a particular issue? We believe it is fair to say that ensuring a safe drug supply has overwhelming support, and affects nearly every American family and home.

To read the FDA’s Draft Strategic Priorities for 2011-2015, click here.

We will be closely monitoring any new developments from the FDA and update you when their finalized plan is released.

– Anna Dunbar-Hester, Program Associate
Prescription Access and Quality