At a hearing yesterday, Senate HELP leadership said they would likely include supply chain safety measures in the major drug user fee re-authorization next year (PDUFA V), and showed bipartisan interest in how FDA is dealing with the challenges posed by an outsourced drug supply.  This is great news given the increasing risks this unevenly monitored supply poses for patients.

Ranking member Senator Mike Enzi asked FDA Commissioner Hamburg what sort of progress the agency was making on the GAO’s recommendations to increase foreign inspections. Hamburg said it continues to be a priority—she has been vocal about closing the regulatory and capacity gaps that allow foreign drug plants to go nine years between inspections.

Of course, Congressional appropriations are a huge piece of FDA’s ability to improve those numbers. And the recent House-passed budget, which lops 12 percent off FDA’s current budget and 21 percent off its 2012 request—not to mention the looming specter of default–would significantly cut into the agency’s efforts to meet its newly global monitoring demands.

FDA Office of Regulatory Affairs’ Dara Corrigan said earlier this week that such cuts would hobble the agency’s foreign inspection efforts, as well as its plans to acquire technology that would make inspections more modern and efficient. The agency has been making strides on foreign inspections, doing 27 percent more between 2007-2009. But that progress now hangs in the balance.

According to Inside Health Policy, Corrigan told the Alliance for a Stronger FDA that FDA might be forced to conduct 2,000 fewer domestic inspections and 9,000 fewer import audits under the House-passed FDA appropriations bill.

“We’ll have to do fewer inspections and we’ll have less flexibility to do surveillance,” she said.

–Kate Petersen, PostScript blogger

Industry user fees are one of the few ways to raise revenue it seems we haven’t heard much about over the past few weeks, as Congress has become engulfed in the debt ceiling debate. But they’re nevertheless a critical piece in funding the FDA’s system to review and approve new drugs, and may also be a key in helping the agency to meet the rapidly increasing challenges of protecting U.S. consumers from safety gaps in overseas manufacturing of drugs and medical devices.

That’s the focus of a Senate HELP committee hearing tomorrow, and the FDA Commissioner Dr. Margaret Hamburg will be there to testify. Hamburg has put these challenges out front in a recent report and public remarks (including at Public Citizen on Monday), and tomorrow’s hearing offers her an important opportunity to discuss what it will take—in resources, authorities and partnerships—for the agency to get from here to there. One industry group, the generic drug trade organization, has already publicly come out in favor of user fees to support better FDA oversight of suppliers.

Here are some questions we think the Senators should consider asking Hamburg:

Pew’s After Heparin report and the FDA’s “Global Pathway” report both pointed again to the fact that companies that make drugs in the U.S. are inspected every 2-3 years, while those that manufacture in foreign facilities only get inspected once every 9 years.

• Shouldn’t we be ensuring that foreign drug manufacturers which operate in many countries with loose regulation have to meet the same standards as U.S. companies?
• Is weak regulation helping to foster outsourcing of U.S. drug manufacturing?
• If manufacturers continue to outsource, is increasing the level of foreign inspections one way to level that playing field? How else?’

The FDA’s report acknowledged that it is a domestically calibrated agency that in the last decade has been asked to monitor a rapidly and overwhelmingly outsourced industry – 80 percent of drug ingredients are now made abroad in countries like India and China.

• Does the law governing the FDA’s mandates and authorities—the Food Drug and Cosmetic Act—match the current challenges created by the complexity of our global drug supply?
• Does the law allow the FDA to adequately monitor and keep safe such an outsourced industry?   If not, what kind of consensus is there around what to do?

Drug counterfeits and thefts can be lucrative for criminals. Stories like the one out of Texas last year, when stolen insulin reached patients after possible mishandling, or when recalled Heparin was found in dozens of California hospitals months after the recall, suggests we sorely need a uniform way to track our drugs as they make their way through the complex chain between manufacturer to patient. And right now, we don’t have one.

• Do you believe we need such a tracing system, and what is FDA’s role in developing one?
• Does the FDA need additional authorities or a statutory mandate to ensure drug traceability becomes a reality?

–Kate Petersen, PostScript blogger

Late last summer, the Association of American Medical Colleges attempted at the eleventh hour to significantly weaken proposed rules to tighten up conflict of interest policies for NIH-funded biomedical research.

Now the rule, which would require institutions to collect and report more information about their investigators’ financial ties to drug and device companies, is facing threats from another corner, as OMB trawls the regulation fountain for small savings.

But looking to detooth or block conflict of interest regs isn’t the answer. We know from ProPublica‘s review of company payments and other recent reports that big dollars from pharmaceutical companies are still flowing into the hands of clinicians, who are often also publicly-funded researchers.  And we know from a series of Senate and media investigations that the current honor system of requiring researchers to report conflicts with the drug industry is broken in big ways.

The new rule would help fix that by creating common protocols and measurements, helping to ensure all NIH-funded institutions are reporting and managing COIs in the same basic way.

The AAMC and AAU’s earlier attempt to weaken the NIH proposal illustrates the difficulty an association that represents so many institutions can have setting a high bar, and there’s sometimes a tendency to recede to the lowest common denominator.

Indeed, many academic medical centers have been very proactive in taking steps to better manage the potential financial conflicts of their faculty. But the Senate’s investigation revealed many medical schools were guilty of lax oversight, and this would help them avoid similar problems in the future.

Recent sanctions of some high profile researchers at the center of the conflict of interest storm, including a prominent group of Harvard psychiatrists, remind us why NIH proposed the new rule in the first place, and of the potential costs of not changing them.

Harvard psychiatrist Joseph Biederman contributed to a 40-fold increase in pediatric bipolar diagnoses between 1994-2003, running NIH-funded research even as he was on the payroll of the companies whose drugs he was studying – netting $1.6 million from the drug industry from 2000-2007 alone. He urged one company to fund a Harvard research center “to move forward [its] commercial goals.”

The explosion of pediatric bipolar treatment is a part of a larger rise of mental health diagnosis and treatment. One in 10 Americans over age six now take an anti-depressant, and the newer class of atypical antipsychotics—about which relatively little is known—is now the top-selling drug class in America.

So how much has this high-stakes blurring of the line between research and marketing cost us?

In its assessment of the new rule, HHS estimates that it will take an institution one hour to review an investigator’s conflict, and two hours a year for an investigator to adhere to the reporting rules. It estimates only an incremental cost for institutions to post the information to a public website, since all of them already have such websites.

So how much is it worth to us to make sure that future leading-edge clinical science–which guides so much medical practice in this country–is done with transparency and objectivity? How much is it worth to improve a system that has clearly been ineffective in ensuring that taxpayer-funded pharmaceutical research is about good science, not good marketing opportunities?

The Administration would do well to calculate all this before watering down important reforms needed to ensure responsible use of taxpayer funds.

–Kate Petersen, PostScript blogger

Last week, Maine’s governor signed LD719 into law, repealing a series of pharma transparency laws including one that required drug companies to report certain marketing costs, including meals and gifts to physicians. I talked with Maine representative and director of the National Legislative Association on Prescription Drug Prices Sharon Treat (D-Hallowell) to find out what this repeal means for her state, the wider transparency landscape, and what we might expect next.

PS: There’s been a lot of action on the state front again at the end of this budget season. Massachusetts protected its gifts ban from some aggressive repeal threats, and now Maine has repealed its disclosure law. Maine’s move doesn’t seem to reflect a bigger consensus. What do you see happening at the state level?

ST: The new Republican governor and majority in the Maine Legislature have together now repealed not only the state’s gift disclosure law, but nearly every progressive prescription drug policy we have, including our pharmacy benefit manager (PBM) law, and pricing transparency.  This is not surprising as there are very close ties between the pharmaceutical industry and the Republican party in Maine. None of these laws were easy to pass in the legislature even when Democrats had the majority, because the drug industry is very powerful when it comes to influencing politicians.

I don’t think the repeals reflect a change in what the public thinks.  In fact, I doubt if most Maine people have any idea what’s been repealed.  This session a lot of attention was focused on proposed repeals of many of our environmental laws, and in that case the public uproar stopped the rollbacks from going forward.  In the case of the pharmaceutical laws, there aren’t strong consumer advocacy groups in the state that have taken up these issues, partly because so many other social policies are on the chopping block at the same time.

PS: There’s a lot of talk about state Medicaid budgets these days. Why is disclosure an important piece of the cost equation, to your mind?

ST: Maine’s gift and advertising disclosure law was enacted originally because legislators wanted to know how much was being spent by the pharmaceutical companies on promotional activities, since the industry claimed that drug prices had to be high in order to support their R & D activities.

The information gathered showed that advertising and promotion outspent R & D.  It helped make the public case for reducing high drug prices.  Then, as the data was collected, more public attention was paid to conflicts of interest and the role of gifts and payments in driving prescribing of the highest priced branded drugs.  It helped open peoples’ eyes to larger issues of safety and appropriateness of prescribing.

Maine also had a law, also just repealed,  that directly collects drug price data from the pharmaceutical companies and requires a person with authority to certify the truth of this data. This independently collected information was a direct help to the state in negotiating very favorable rebates and limiting pricing fraud under the Medicaid “best price” requirement (nationally major drug pricing fraud cases are common).  Maine gets a return on average of about 50 percent of its Medicaid drug spend back in rebates, and having this check on drug company pricing reports has helped avoid fraud and keep our Medicaid prescription drug budget in line, with minimal increases over the years.

PS: Your colleague, physician Linda Sanborn, also supported the Maine transparency law, and state physician groups have supported similar bills and laws elsewhere. Have you heard from Maine physicians on the repeal, and next steps?

ST: Dr. Sanborn spoke eloquently in the floor debate about the need to have public disclosure of the clinical trials data- another law that was repealed.

Fortunately, federal laws will eventually pick up the slack on both the clinical trials database and reporting on gifts and payments, but the Legislature’s majority did not support even linking our state website to the federal databases.  All of the Democrats on the Health and Human Resources Committee strongly supported these laws and spoke to the issues.

The physician groups were most active trying to prevent the repeal of the academic detailing program, which they are now very involved with implementing.  Although the funding was reduced, this program did stay alive in part because of their advocacy.

In terms of next steps, it would be foolish to try to reverse these repeals with the current Legislature and governor.  If Maine people want a different result (and understand what has happened) then they will elect different people the next time around.

I was actually shocked that so many legislators who ran for office on platforms of preventing fraud and abuse passed two laws that repealed effective anti-fraud laws– the PBM law repeal and the pricing disclosure law. These repeals will hike the costs of the Medicaid program (as confirmed by the Legislature’s fiscal office in the fiscal note on the legislation).

PS: Transparency of industry marketing relationships with prescribers isn’t going away. Taking the long view, what can we expect next?

ST: I think we will see a more active media in Maine looking into the federal doctor payment databases and the financial links between big pharma and Maine politicians.  I expect that there will be more awareness going forward about these conflicts of interest.  My hope is that this awareness will once again lead to taking action with public support and a more receptive legislature and governor.

–Interviewed by Kate Petersen, PostScript blogger

The shipment of your birthday present from distribution to delivery can be tracked. A sticker in the grocery store tells you where your pineapple was grown. A tag in your t-shirt says where it was made. Your new car lists where its component parts are from, and where it was assembled. But if you rely on anything from Tylenol to cancer treatment, you have less information about where those drugs came from and what path they took to get to you.

That’s just one startling fact in a new report released today by the Pew Health Group. After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs echoes the FDA’s recent call to overhaul the system that monitors imported drugs, and puts forward a number of recommendations to close those safety gaps.

“Consumers should be alarmed by the increasingly complex, globalized, and outsourced drug supply chain described in the After Heparin white paper,” Robert Restuccia of Community Catalyst said in a statement. Community Catalyst has teamed with Pew to advocate for many of the recommendations in the report, and leads the broad-based Alliance for a Safe Drug Supply.

“After Heparin shows that outsourcing is growing and is a business strategy for all types of prescription and over-the-counter drug producers,” he said. “As one major brand-name drug maker put it: ‘If we can buy it cheaper than we can make it then of course that’s what we’re going to do.’

And indeed, the numbers bear that out.  When it comes to drugs, the U.S. import deficit on pharmaceuticals grew to $18 billion in 2008, and it is estimated that 80 percent of pharmaceutical ingredients and 40 percent of all finished drugs in the U.S. now come from overseas.

As we’ve written about here in recent weeks and months, there’s been surprisingly broad consensus from industry, regulators and the public that the system in place to monitor these imports is broken down and in urgent need of fixing. Last year, 94 percent of pharmaceutical executives surveyed said using foreign-made raw materials was risky.  And in a different poll, the same percentage of likely voters wanted FDA to be able to recall unsafe or adulterated drugs, as it can for food. Only Congress can give the agency that power.

At the Pew After Heparin conference in Washington D.C. in March, which informed today’s report, we heard that everyone should be inspected by somebody—and that companies should be fully accountable for checking out factories and quality conditions prior to contracting with a supplier.  We heard that in this fractured supply chain, industry actors needs to work with each other and with regulators to share information they may receive on potentially dangerous or counterfeited drugs, and that a uniform tracking system to help verify a drug’s path from factory to pharmacy is sorely needed, but will most likely require the force of law to achieve.

Recently, we talked with pharmaceutical expert Prabir Basu about the importance of investing in good manufacturing science – both on the design side, and ensuring that the tests used to detect false or substandard medications are state of the art.

We talked with California Board of Pharmacy Director Virginia Herold, who illustrated the importance of having a national tracking system for drugs that enter our homes and hospitals.

We heard from API manufacturer Brant Zell, who said the FDA has had its hands tied for years when it comes to fulfilling its mission to ensure the safety of foreign-made drugs. Zell said he thought that the heparin crisis in 2008 would be the straw that broke the camel’s back, and moved Congress to act. To date, that’s not been the case.

We’ve seen the FDA go before Congress to ask for the authorities and tools to do a better job of ensuring the quality and safety of drugs before they get to U.S. shores, and keeping ones that don’t meet quality standards out and off the shelves.  So far, Congress has yet to act on those requests.

At a hearing last week, some in Congress again pledged to take action and pass a law that would guide the building of these industry quality rules and give the FDA the authorities it needs to oversee a terribly complex and global supply chain. Today’s report reminds us that there are enough gaps in the supply chain to exploit and economic incentives to do so that the clock is surely running on another heparin-like crisis. The time to act is now.

You can read the full report or watch a webcast of the March conference here.

–Kate Petersen, PostScript blogger

Watching today’s Energy and Commerce subcommittee hearing on “PDUFA: Medical Innovation, Jobs and Patients” was a little like watching a tennis match and a hockey game at the same time: It was possible to keep track of where the ball and puck were, but you had to remind yourself that the net meant two different things.

Republicans who outside the committee room have backed aggressive budget cuts for the FDA, leaned on the agency to relax everything from new drug approvals to conflict of interest rules (plus engaged a little post-game scolding over last week’s Avastin hearing.)

Meanwhile, longtime committee members and drug safety advocates Reps. Henry Waxman and John Dingell pointed to persisting gaps in the FDA’s resources and authorities that have left the U.S. drug supply vulnerable to another heparin-like crisis, and to a bill—HR 1483, the Drug Safety Enhancement Act—that would finally close many of those gaps.

“It is in no one’s interest to have a weak FDA,” Waxman said. “If Americans lose confidence in the FDA, they will lose confidence in the pharma industry as well. The FDA needs the resources to protect us for unsafe drugs, and to be sure these drugs work.”

The FDA’s representative at the hearing, Dr. Janet Woodcock, mostly stayed on message (with the exception of some flummoxed finger-pointing at the FDA field inspector’s union when asked about the agency’s difficulty inspecting enough foreign drug-making facilities.) Her message was: FDA’s job is to keep patients safe, and make sure drugs work. The agency is an important piece of the innovation pipeline, she said, not an impediment, but it also lacks some resources and authorities it needs to fully carry out the safety part of its mission.

Woodcock incisively turned back some Members’ suggestions that a dried-up development pipeline was FDA’s problem. She highlighted improving approval trends and pointed to a recent McKinsey study of phase three failures which found that 50 percent failed because the formulation worked no better than a placebo.

“It’s really hard to blame that on the FDA,” she said.  Woodcock also warned against thinking safety problems are the sole province of generic drug makers.

“Heparin was not a generic drug,” Woodcock said. “This is not a generic drug problem–this is a pervasive drug quality problem.”

Concern for the FDA’s ability to protect the supply of imported drug and raw materials coming into the U.S. came from both sides of the witness table. The Pew Health Group’s Allan Coukell said in a report due out next week, his group found surprising consensus among stakeholders and likely voters for more industry-led quality improvements, legislative solutions like the ones in HR 1483, and FDA inspections. In fact, he said, generic makers and API manufacturers have said they are willing to pay more for additional inspections.

But Congress hasn’t acted, he said.

Texas Rep. Burgess said he was waiting on FDA to finish its investigation of the 2008 heparin crisis. But Coukell suggested that’s a mistake.

“Heparin illustrates a lot of weaknesses that we know about now. It was a wakeup call—FDA and others have said that. And I think we do know what we need to know.”

But, perhaps it was senior committee member John Dingell who best illustrated the short distance we’ve gone since the heparin crisis three years ago. (Sadly, PostScript had some hearing deja vu to last year, when former Deputy Commissioner Joshua Sharfstein answered many of these same questions, asking Congress for a series of critical powers it hasn’t granted yet.)

Dingell asked Woodcock for yes or no answers to a series of rapid-fire questions.

Do you have, he asked:

–the ability to control the safety of pharmaceuticals imported into the U.S.?
–the authority and resources to control the safety of raw materials coming into the U.S.?
–the necessary resources to ensure overseas drug manufacturers are properly observing Good Manufacturing Practices (GMPs)?
–the necessary resources to ensure that raw materials suppliers also engage in GMP abroad?
–the resources to inspect foreign facilities with the same frequency as domestic ones?
–the ability to share findings on inspections or quality problems with trusted regulatory partners?
–the authority to require a manufacturer to notify you if they suspect a drug has been counterfeited, adulterated, or      misbranded?
–the power to refuse imports you suspect of being counterfeit or adulterated at the border?
–the authority to recall drugs you believe to be substandard or unsafe?
–the authority to recall imports and raw materials?

To each of these, FDA’s Woodcock gave an immediate, square answer: No.

How often can you get by to see foreign drug manufacturing facilities? Dingell asked.

Every nine years or so, Woodcock said.

And dog food making facilities? he said.

About every year, she said.

Do you need these additional authorities? Dingell asked.

Absolutely, Woodcock said.

Would HR 1483 have afforded you the authorities you need to deal with the heparin problem?

Yes, she said.

–Kate Petersen, PostScript blogger

Virginia Herold is the executive officer of the California State Board of Pharmacy. In her role there, Herold works closely with and advises the 13 Board of Pharmacy members in the development of policy and in the administration of the board’s enforcement, licensing and regulatory programs to further the board’s consumer protection mandate. The Board regulates over 130,000 licensees in 13 separate regulatory programs including pharmacists, pharmacies and drug wholesalers.

Herold talked at the Pew Health Group After Heparin conference in March about finding recalled heparin in California hospitals during the 2008 heparin crisis and how the state has moved to prevent future safety failures. I caught up with her again last week to talk about how recalled drugs get back into the drug supply, why counterfeits can be so hard to track down, and how we might begin to fix the system.

PS: Your talk at the After Heparin conference in March showed a recall system that is really broken – nearly 8,000 patients in California were exposed to heparin after the recalls began. How did such a broken system become the standard, and how do we start to fix it?

VH: I’m not certain what the solution is. However, we do know wholesalers and pharmacies do not track drugs by lot number or expiration date, which is how manufacturers issue recalls. The manufacturer will release the lot number and expiration date—info that isn’t really available to the wholesaler and pharmacist except by a visual check. That is very difficult given the large number of drugs moving through the pharmaceutical supply chain, and especially considering number of recalls we’re having now.

Secondly, the distribution systems are relatively complex, especially in a hospital setting. Some drugs are in the pharmacy. Some are outside the hospital pharmacy on the floor in carts. Some are on Pyxis machines.

A perfect example of the complexity of a recall call is [last week’s] recall of Tylenol, which is an over-the-counter product, but the recall complexity is similar.  Right now, some of those products are in transit — in boxes, crates or pallets on trucks. Two days from now when those trucks unload those drugs, unless they are caught on the other end, may not be pulled as part of the recall (because the recall occurred Wednesday, and the receiver of the drugs missed the search review that happened Wednesday or figures the recalled drug product would not have been shipped.)

And we’ve learned that even when recalled drugs are returned to the wholesalers as part of the recall, they may be inadvertently placed back into active stock and then reshipped to new pharmacies.  We saw three instances of this with the heparin recall, where a batch of the returned drug isn’t quarantined, and then, because it is still part of active stock, the recalled product was shipped to another hospital.

Another problem is the use of the world “voluntary” on a manufacturer’s recall notice.   The manufacturing companies initiate these recalls, sometimes after the FDA finds a problem and asks them to recall a drug, more often on their own.  If a problem appears and the manufacturer doesn’t act, the FDA can take action, but it rarely does this.

Typically the manufacturer “voluntarily” recalls the drug from the supply chain. Recalling a drug is perhaps the most sensitive thing companies will do. And so recall notices are carefully worded, and often use the word voluntary.  But when that recall notice lands on the pharmacist’s desk, he or she doesn’t always recognize that it doesn’t mean voluntary on the part of the pharmacy to take action. It means the pharmacy should take action to remove it, and not dispense it to patients.

I think we need to recognize upfront that the recall system needs to be in the hands of the FDA as the regulator.   You don’t want every state to set up its own separate system. Drug distribution is national, it needs a national solution.

PS: There’s been a lot of talk in the last week or so about drug shortages and FDA’s role in them. How do shortages figure into this equation?

VH: Sometimes the recall of a drug could cause a shortage of a drug for practitioners and patients.  Other times a shortage may be due to other factors.  One issue here is an ethical question: what if a recalled drug is the only drug appropriate for treatment and there is no other substitute drug available?  If the removal of the drug from the market is done for a health care reason, and it’s a necessary drug, is it better to have a contaminated drug, or no drug at all? Should the recalled drug be provided in such circumstances, and what type of consent should occur if this is the only lifesaving solution?

How do you decide? Should there be some consent form for patients facing a severe condition and their providers that says: this drug has been recalled but there are not other options available? These questions are way out of my pay grade–the FDA should be deciding that.

The FDA’s in a tough spot, too. They are expected to keep the drug supply safe, but with all the manufacturing of drug products and ingredients off-shore, they don’t have the resources to inspect everything worldwide.  If you are the patient that needs a drug or a treatment, you want anything that’s available anywhere in the world that will help you. But in the U.S., the FDA has to approve the drug before it is sold.

PS: In the case of heparin, I understand FDA asked Baxter to wait on a full recall until enough alternative supply could be procured.  How do you think about potentially contaminated drugs that may have still been in circulation?

VH: In April or May 2008, we somehow heard that 50 percent of the total heparin products were unavailable due to the multiple recalls. Actually, we discovered recalled heparin still in California hospitals after the recalls because we were beginning to have concerns about the shortage of this drug.

In late March 2008, a pharmacy director told me they had received a fax in the pharmacy offering heparin at $130 for an amount they used to pay $8 for. Such offers concern us as regulators, because it immediately connects – we probably have unlicensed activity and possibly counterfeit or diverted drugs.  If the licensed wholesalers cannot obtain a drug, where is this supplier getting the drug?

So we started off by inspecting 40 hospitals.  We thought we were going to find counterfeit heparin in the hospitals and unlicensed sales to hospitals. Instead, we found recalled heparin in 40 percent of them. We never even got around to searching for counterfeit drugs because we were so concerned about the recalled supply still in hospitals, and a climbing death count nationwide from exposure to it.

PS: As I understand it, right now pharmacies and distributors don’t have to tell the FDA when they suspect a drug has been stolen or adulterated.

VH: In California, if someone has knowledge of, or reason to believe a drug has been adulterated or counterfeited, they are required to report that to the Board of Pharmacy.

PS: And at the Board, are you required to tell the FDA?

VH: I am not aware of a specific law requiring this, but by practice we tell the FDA everything of such a nature that we find. They have bigger field of vision — and if it’s happening in California, there’s a pretty good chance it’s not just in California.

In terms of counterfeit prescription drugs, we have had some rare problems here stumbling upon a couple of counterfeit drugs.  It is hard to detect a counterfeit drug. There’s nothing in a pharmacy that shines for us with neon light saying:” This is a counterfeit, come over here!”   In some cases, a patient will stop responding to a medication. Usually when that occurs, no one even suspects the efficacy of the drug itself.  More typically the therapy is no longer working, switch to a new one.

Right now California, like the rest of the nation, has a problem with prescription drug abuse.  This means there is high demand for certain types of prescription drugs, which leads to drug diversion from the supply chain.

And the economy is bad.  So some of our licensees may get offered a great deal on a drug from someone they don’t normally do business with.  Nobody stops to think ‘Why am I getting this good deal?’

People trust the drug supply in the U.S.  But when drugs are bought and enter the supply chain by any of the supply-chain partners through unauthorized means, it’s hard for the other partners to identify this.  It is like buying that TV out in the Wal-Mart parking lot: It’s a good deal! But we need to ask why it is a good deal.

PS: How does California’s e-pedigree law fit in?

VH: We believe that this will greatly aid all supply chain partners in ensuring the visibility and lineage of where a particular drug container has been: who has owned it at every step, back to the manufacturer.  The system requires a certification of each sale and purchase down to the pharmacy level that will make it harder to introduce drugs at any transaction in the pharmaceutical supply chain.  This information will be available by reading a code on the container.  There is a need to review information readily, and in a certified way, that holds everyone accountable. A weak link in the supply chain undoes all the security, compliance and care that’s been used by other supply chain partners.

We don’t want the quality of the drug supply in the U.S.  to come into question the way it has in some other countries.  The U.S. still has a strong secure drug system, but we see some faults in it, and we are working to plug these.

The public doesn’t need to be afraid or overly suspicious of their drug supply—they just need to be a bit cautious.  And to beware of Internet drug buys where you can obtain drugs without a prescription or from an unlicensed pharmacy.  A great deal of counterfeit medication is obtained this way.

–interview by Kate Petersen, PostScript blogger