Wednesday, September 03, 2008

Federal Pedigree Sand Trap

As I pointed out yesterday, the California serialized e-pedigree law will likely be delayed until 2015. Unfortunately, the federal situation will not provide a quick solution, leaving us with the prospect of managing our crazy patchwork of inconsistent state laws for the next few years.

Key question: How will the FDA play the new California 2015 timeline (assuming Governor
Schwarzenegger signs the bill)? Will the FDA:
  1. Implement national serialized e-pedigree in sync with a new California timeline?
  2. Embark on a national effort that would preempt the California law prior to 2015?
  3. Do nothing and hope everything turns out OK?
My guess is at the bottom.

Pharmacists Keep Federal Track-And-Trace in the Clubhouse

Representatives Steve Buyer (R-IN), Gene Green (D-TX), Jim Matheson (D-UT), and Mike Rogers (R-MI) co-sponsored H.R. 5839 Safeguarding America’s Pharmaceuticals Act of 2008. I applauded this bill when it was introduced in April, although the bill has only garnered 11 co-sponsors and has no Senate counterpart.

H.R. 5839 was going to be incorporated into other related FDA legislation, but intense behind-the scenes lobbying against the bill has now killed that option. Paul Kelly, NACDS vice president of government affairs, recently boasted: “We remain very pleased that Chairman Dingell has decided not to include an electronic pedigree requirement, and more importantly the track-and-trace requirement, in that bill.” (source)

As you may recall, NACDS sponsored and promoted questionable calculations from sometimes track-and-trace advocates Accenture. Unfortunately, my dissection of Accenture’s study probably cost me the chance to have lunch with spokesgolfer Tiger Woods. Oh well.

In the meantime, Federal progress will likely be slow without (a) a new push by the FDA, and/or (b) a compelling trigger event, such as counterfeit drugs discovered in a retail pharmacy.

FDA Still not on Back Nine of PDMA

Meanwhile, the FDA remains stymied in its attempts to implement the pedigree regulations of the Prescription Drug Marketing Act (PDMA) following a December 2006 injunction.

The PDMA requires, among other things, that secondary wholesalers provide a pedigree prior to each wholesale distribution of prescription drugs. The requirement to pass a pedigree applies to those wholesalers who are not authorized distributors of record (ADRs) for the prescription drugs that they distribute.

In July, the U.S. District Court for the Eastern District of New York “affirmed” the preliminary injunction against the FDA in the case of RxUSA Wholesale, Inc. v. Department of Health and Human Services (HHS). See the FDA’s Backgrounder re: RxUSA Wholesalers, Inc. v. HHS for more. So, no PDMA pedigree, either.

FDA in the Rough

The Food and Drug Administration Amendments Act of 2007 requires the FDA to establish technology standards for the pharmaceutical supply chain by 2010. The FDA requested comments and information earlier this year – see the links in The FDA and EC Dive into Supply Chain Security.

Although the FDA has not decided on its next step, I presume that nothing will happen until after the Presidential election and a possible new FDA commissioner.

among the three options listed at the top of this post, I'm voting for Option 1 but fear we may end up with option 3.


  1. I'm not sure why you say there has not been any cases of counterfeits. This is really recent with one of the major wholesaler's (Cardinal)subsidiary (Medicine Shoppe). I'm sure someone is trying to keep this one on the down low, since this happened at the same time CA passed their most recent bill to delay.

    Patients who have received any of the following drugs should contact their physician for new prescriptions.

    Aug 12, 2008
    By: Judy Chi
    Drug Topics Daily News

    The Food and Drug Administration has issued an alert about two pharmacies in Baltimore suspected of distributing expired or counterfeit drugs. The agency said patients who have received the following drugs should contact their physician for new prescriptions:

    Lisinopril (20 milligrams)
    Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
    Gabapentin (100 mg, 300 mg and 400 mg)
    Metoprolol (50 mg)
    Nifedipine (30 mg)
    Diclofenac Sodium (30 mg)
    Glucophage (500 mg Extended Release)
    Glucovance (125 mg and 500 mg)
    Glipizide/Metformin (2.50 mg/250 mg)
    Furosemide (20 mg)
    Tamoxifen Citrate (10 mg)
    Metformin HCl ER (500 mg)
    Calcitrol (0.25 micrograms)
    The two pharmacies in question are at 8035A Liberty Road and 5900 Reisterstown Road and are managed by Pamela Arrey, R.Ph. According to Joseph Kum, an attorney for Arrey, his client denies the charges and maintains that the drugs under investigation were obtained from charitable organizations and were never meant for interstate commerce. Rather, some drugs were in drums being prepared for inspection and some drugs were in totes getting ready for destruction. They were not on the pharmacies' shelves for sale, he said. FDA said pharmacies outside of these two locations show no evidence of being involved.

    Drug Topics contacted Medicine Shoppe's parent, Cardinal Health, for a response and got the following reply: "Medicine Shoppe International, Inc. (MSI), the franchisor of Medicine Shoppe pharmacies, has learned that two of our system's Baltimore-area pharmacies, located at 8035A Liberty Road and 5900 Reisterstown Road, were recently found by the Food and Drug Administration (FDA) to have sold expired medications. Medicine Shoppe pharmacies are franchised businesses and the individual pharmacist or franchisee who owns the store is responsible for all business decisions and practices. MSI is taking this matter very seriously. The health and welfare of our customers is our system's main priority, and we do not condone these types of infractions by our licensed pharmacies. Medicine Shoppe pharmacists have received national recognition as dedicated professionals who provide excellent customer service."

  2. I'm not sure why companies are not looking at brand protection. In a down economy it appears the prevelance is growing since their is no way to track the product thru the supply chain and it's an easy way to make $$$.

    European Alliance for Access to Safe Medicines (EAASM) found that 62 percent of medicines purchased online were counterfeit

    Fake Pharmacies and Brand Jacking on the Rise

    Aug 27, 2008
    By: George Koroneos, Online Content & News Editor
    PharmExec Direct Marketing Edition

    On Tuesday, brand protection firm MarkMonitor released its latest "Brandjacking Index," a study that tracks the online presence of six major drugs to determine if the products are being sold by shady pharmacies, used in spam e-mail, or being counterfeited outright.

    The numbers aren't pretty. In June 2008, MarkMonitor found more than 20,000 Web sites abusing drug trademarks. That included 2,986 suspicious online pharmacies delivering 60 million spam e-mails.

    Of the pharmacies documented, only two are certified to sell drugs by the National Association of Boards of Pharmacy. Yet the pharmacies in the study had estimated annual sales at nearly $13 billion based on an average transaction of $70, according to the report.

    While the six drugs are not named, they include a lifestyle drug, a sleep aid, anti-cholesterol, and an ulcer medication.

    "The brands are not the only victims of these types of abuses," said Te Smith, vice president of communications at MarkMonitor. "There's a very real effect on consumers of these brands. Consumers' health could be at risk. You might think that you are taking a life-saving medication form a major pharmaceutical brand, yet someone is out there prescribing a diluted or fake version."

    The biggest increase, year-over-year, is an 87 percent boost in offensive content on sites that are marketing pharmaceuticals. More worrisome is a 66 percent spike in e-commerce sites marketing pharmaceuticals, which jumped from 3,052 in the second-quarter of 2007 to 5,070 in the same period this year.

    While the number of bogus online pharmacies is growing, so is the traffic at the sites and the deep discounts being offered. Smith also noted that these sites are engaging in paid advertisement to draw consumers.

    In terms of search engine advertising, MarkMonitor only used the brand names in the search filter, which isn't exactly how most consumers search for drugs. Patients often search for a condition rather than a brand name. The survey found almost 11,835 search ads using the six drugs, representing $26 million in average annual ad spend. None of the links connected to sites certified by the National Association of Boards of Pharmacy's Verified Internet Pharmacy Practice Sites (VIPPS) certification program, and none went to the relevant pharma company.

    Hometown Disadvantage
    Think these sites are all overseas? Think again. While the actual location of the pharmacy is unknown, 49 percent of the companies are using US hosting facilities and services. The next highest location is the UK, with only 12 percent. Smith notes that many of the pharmacies are working through different countries with billing done from one country, hosting from another, and shipment from somewhere else.

    For example, one online pharmacy allegedly based in Canada uses a Web hosting service in Russia, and has a phone number with a Texas exchange. The site only sells single doses and has false accreditation.

    "That said, if the location is in the US, brand holders would have a much easier time taking legal action than trying to do something across national jurisdiction," Smith said.

    The average drug at a non-VIPPS site is $2.54 compared with an official site that has prices at $10.54 on average. MarkMonitor purchased a number of products from the online pharmacies that it profiled, and plans to test the efficacy of the drugs if and when it receives them.

    FDA recently said that it was doing everything in its power to stop illegal pharmacies. In June, it sent 25 warning letters to online companies engaging in fraudulent marketing of fake cancer medication. The agency also posted a list of signs that consumers could use to denote a potentially illegal Rx dealer.

    "It's going to take a combination of both industry and government working together to clean this up," Smith said. "Gone are the days of Web sites with spelling errors and sloppy grammar—these sites look real. As a result they are prolific and are going to target brands that aren't aggressive in stopping them."

    In related news, a new report issued in July by the European Alliance for Access to Safe Medicines (EAASM) found that 62 percent of medicines purchased online were counterfeit, while 95.6 percent of the pharmacies were operating illegally.

  3. Pharma can only track a portion of their product so now we as consumers pose the risk of taking product which should have been taken back in a recall. Pedigree/Serialization would help improve visibility. I'm really surprised this continues to get pushed back when there is tons of data which supports it. I guess we as consumers just need to wait for the big one. I seen the lawyers were already setting up websites for both the Heparin and counterfeit drugs at the Medicine Shoppe. I guess until pharma gets hit big they will start to perceive the risk is greater then the cost.

    Heparin recall only partially successful, say California authorities
    Date: 2008-06-27

    Problems in locating product stocks in hospital pharmacies are a justification for the state’s pedigree program, they say

    During a teleconference presentation at the 4th Global Forum on Pharmaceutical AntiCounterfeiting (Washington, DC, June 4-6, sponsored by Reconaissance International), Virginia Herold, executive director of the California Board of Pharmacy (CBOP) reported that the heparin recall that occurred during this spring has only been partially successful. Recalls had been issued by FDA and, among others, Baxter Healthcare, several times since contaminated vials of the blood treatment were found early in the year. According to press reports, upwards of 83 patients have died nationally as a result of receiving the apparently sub-potent product—making the recall a high priority throughout the healthcare system.

    Yet, through May, upwards of 18% of the 500 hospitals in California still had unrecalled product in their stockrooms. More damning still, some dosages were found that had been returned to intermediate distributors—and then sent out again. CBOP is the central organization in California that has been negotiating with the manufacturers, wholesalers and others over the implementation of California’s e-pedigree program, now scheduled to go into effect in January 2011. In discussing the aggressive stance of CBOP relative to other states’ pedigree programs, Herold cited the heparin recall as an example of how better control of the pharmaceutical supply chain would be beneficial to patient safety.

    Through mid-April, Baxter Healthcare reported that it had been named in about a dozen liability lawsuits, but that the heparin product line represents a very small portion of its business, and that it had not yet made a decision whether to re-enter the heparin market. “The supply chain management issues surrounding biologics are complex and different [from conventional pharmaceuticals],” said chairman and CEO Robert Parkinson. “We want to make sure that supply chain is controlled as effectively as possible.”

  4. "Where'd it go?"

    "Right in the lumber yard."

  5. Adam, do you think the 2015 date is too far out? Take into consideration that easily over $100M has already been spent by the top 10 pharma manufacturers. Add in everyone else and the wholesalers and the number is over $200M easy, which is now throw-away money. In the world of pharma that may not be that big of a number, but it still seems pretty wasteful. What date would have been fair to expect compliance and allow the companies to use at least some of the knowledge/efforts they have invested.

  6. Right in the lumber yard? You must not have been being the ball.