Pedigree issue dogs distributors. Should IMDA members sweat a Dec. 1 law dictating pedigree for pharmaceuticals? Some say “yes.” Vendor-access guidelines issued. A provider/supplier task force issued a set of voluntary guidelines for vendors’ access to hospitals, which it hopes will help bring some consistency to the industry. Commercialization Part 2. IMDA member Dave Campbell tells a group of manufacturers, venture capitalists and others about the role that specialty sales and marketing organizations can play in helping manufacturers bring innovative medical technologies to market. Planning for pandemic flu. Government offers checklist for business owners. FDA promises to expedite innovation. The Food and Drug Administration says it’s serious about helping manufacturers get innovative medical devices to market faster and with a better safety record.
Drug wholesalers, particularly small, independent companies, are sweating out the days until Dec. 1. That’s the day a federal law is set to go into effect requiring that all but a handful of the largest wholesalers produce a pedigree on the pharmaceuticals they buy and sell. The question is, should IMDA members – most of whom don’t sell pharmaceuticals – be concerned? IMDA member Stan Tangalakis says the answer is yes. A pedigree is a record of who made a pharmaceutical (and when and where), and from whom it was bought and to whom it was sold -- all the way until its consumption by the patient. By documenting the path that drugs take throughout the supply chain, pedigrees are designed to cut out counterfeiting and other unsafe practices. What gives so-called secondary distributors (that is, those who purchase pharmaceuticals from wholesalers rather than direct from manufacturers) the creeps is a provision in the so-called Final Rule that exempts authorized wholesalers (that is, those who are large enough to buy directly from the manufacturer) from producing them. Small and independent wholesalers fear that because authorized distributors are not required to give them pedigrees, the smaller firms won’t be able to provide their customers documentation from the point of manufacture. For that reason, they fear they could be shut out of business after Dec. 1. The smaller companies argue that the government should either force authorized wholesalers to provide pedigrees to secondary wholesalers, or demand that secondary wholesalers provide pedigree back to the authorized wholesaler only, instead of the manufacturer. There’s another catch: The government’s definition of “pharmaceuticals” is broad. It can include surgical kits and trays, lidocaine and prefilled syringes, according to Jennifer Alfisi, former director of government affairs for the Health Industry
Distributors Association, Alexandria, Va. And there has even been talk of extending pedigree laws to medical devices, though that hasn’t occurred…yet. Lawsuits Tangalakis is concerned about the issue, to the point of giving assistance to one wholesaler – Port Washington, N.Y.-based RxUSA – in a class-action lawsuit it initiated against the Food and Drug Administration, which will enforce the Dec. 1 rule. Tangalakis is also spreading the word about a lawsuit filed in July by RxUSA against a number of drug manufacturers and national wholesalers, accusing them of conspiring to shut secondary wholesalers out of the market. Tangalakis has sent letters to lawmakers, in which he pointed out that: 1) the big wholesalers have been reluctant to give companies such as Mercury verification or validation of the drugs Mercury purchases from them; 2) at least one of the big companies, McKesson Corp., has stopped shipping to secondary distributors in Florida; and 3) drug manufacturers have refused to list Mercury as an authorized dealer of record. (No lawmakers have responded.) “We’ve been licensed by the state, and we’re ethical operators of our business,” says Tangalakis. Even if manufacturers won’t consider companies such as Mercury Medical to be authorized distributors, because of insufficient volume, Mercury and others should be considered extensions of the big wholesalers, he says. “Why can’t we, as a licensed pharmaceutical distributor, be audited three or four times a year, so [the government and public] is assured we are buying through an authorized distributor?” asks Tangalakis. In a letter to drug manufacturers, Tangalakis made essentially the same case, calling for them to “assist in influencing a more rational, logical approach, which is a logistically sound distribution channel…incorporat[ing] the following -- manufacturer, authorized distributor of record, distributor, to end user.” Concerns about where it might lead Tangalakis doesn’t dispute the need for the tracking of drugs throughout the supply chain, but he is worried that if current legislation stands, smaller wholesalers will be forced out of business because they cannot produce pedigrees. At least one wholesaler – AmerisourceBergen –has begun offering a pedigree service. For at least $5,000, the company will make pedigrees available to smaller companies out of its Orlando, Fla., distribution center. A company spokesman said the $5,000 fee would help the company recover its cost of providing pedigrees. “We’re not making money on this,” he said. Relatively few wholesalers – less than 50 – had availed themselves of the service at press time. Tangalakis is also worried about the onerous requirements to which pedigree legislation might lead. Procedural packs, for example, might contain multiple drugs. “If we have to authenticate those drugs, how do we do that?” he asks. Tangalakis has one more concern, namely, that the clamor for pedigree will extend to med/surg devices. Thus far, devices have been spared from pedigree legislation, but the topic has been raised. He believes that the FDA’s interest in the so-called unique device identifier, or UDI, does not bode well for device distributors. (See “Got your number,” September 2006 IMDA Update.) And Mercury is already facing a $400 licensure fee from state of Louisiana for the privilege of shipping drugs and devices into that state. In instituting the fee, the state referenced the Prescription Drug Marketing Act of 1978, the same law that has led to most pedigree legislation.
A provider/supplier task force issued a set of voluntary guidelines for vendors’ access to hospitals, which it hopes will help bring some consistency to the industry. The “Management Guidelines for Vendor Access” was developed by the Strategic Marketplace Initiative and are available on its website, www.smisupplychain.com. SMI is a non-profit organization comprised of providers and suppliers whose goal is to provide a venue where teams can work together to address industry issues and implement best practices. The guidelines define two kinds of sales reps -- those who primarily serve in clinical support roles, providing assistance to the patient care staff; and those who do not.
Non-clinical reps The guidelines suggest that sales reps who do not serve in a clinical support role present documentation as evidence of the rep’s competencies, training and qualifications in:
A written statement from the company should serve as adequate documentation, according to the guidelines. Other possibilities include Internet-accessed database records, education/training documentation, providers’ documents, and documentation from the sales rep’s company management regarding the rep’s background. The guidelines suggest that the healthcare facility provide the rep with educational materials, including information on the following:
Sales reps should disclose to the provider any apparent or potential conflicts of interest that may exist in the rep’s relationship with the provider, including family, personal or financial relationships. What’s more, the guidelines suggest that vendor companies conduct background checks on their reps at the time of hire. If requested by the provider, the vendor should provide confirmation letters. Clinical reps Reps who assist providers in patient care areas – as do those from most IMDA member companies -- should meet all the above requirements and then some, according to the guidelines. Such reps should provide written proof of their immunization status, i.e., tuberculosis, hepatitis B, measles, mumps, rubella and chicken pox. (The provider should protect this information using HIPAA controls.) In addition, reps should provide evidence of training on the following topics:
The voluntary guidelines were distributed in August on CD to attendees of the annual conference of the Association for Healthcare Resource & Materials Management.
IMDA member Dave Campbell last month told a group of manufacturers, venture capitalists and others about the role that specialty sales and marketing organizations can play in helping manufacturers bring innovative medical technologies to market. The venue was “Successful Strategies for Getting Your Products to Market,” a one-day workshop in Los Angeles presented by the Medical Device Manufacturers Association (www.medicaldevices.org) in cooperation with Vector Resources L.C. (www.vectorresources.com). Local coordination was provided by the Southern California Biomedical Council (www.socalbio.org). It was the second such workshop on which MDMA and Vector Resources have collaborated. The first was held in March in Burlington, Mass. (See April 2006 IMDA Update.) The workshop was designed to help medical device manufacturers choose the best strategy to bring their products to market, including specialty distribution, independent reps or a direct sales force, says Rick Davies, managing partner, Vector Resources. In addition to Campbell, a representative from the Health Industry Representatives Association and a direct-selling manufacturer talked about different approaches to market. Other options, such as selling one’s company or finding an OEM partner, were discussed as well. More commercialization workshops are being planned for the future.
Pandemic flu, should it attack, will affect IMDA readers three ways -- as suppliers of much-needed medical supplies and devices, as business owners with employees, and as family members. The federal government and healthcare professional societies, including the Association for Resource and Materials Management (www.ahrmm.org), are drawing up plans to help providers plan for shortages of supplies and devices. But, as the Centers for Disease Control and Prevention points out, “In the event of pandemic influenza, businesses will play a key role in protecting employees’ health and safety as well as limiting the negative impact to the economy and society.” To help business owners plan for pandemic influenza, the CDC offers a “Business Pandemic Influenza Planning Checklist” on its website. The checklist is designed to help business owners assess their readiness in the following areas:
To view the checklist, go to www.pandemicflu.gov/plan/businesschecklist.html.
The Food and Drug Administration says it’s serious about helping manufacturers get innovative medical devices to market faster and with a better safety record. The agency recently announced its Medical Device Innovation Initiative, designed to “promote early interaction between the FDA and industry to optimize review times and foster innovation.” IMDA member might want to refer their manufacturer partners to http://www.fda.gov/cdrh/ocd/mdii.html to learn more about the initiative. In its announcement, the FDA pledged to: 1. Disseminate information about its review process – including regulatory requirements and review procedures – to increase the consistency and transparency of the process. The agency also intends to release an intercenter guidance document on innovative combination products. “This guidance will outline scientific, clinical and technical issues that should be considered early in the development process,” according to the agency. “We believe the guidance will aid developers by explaining how to leverage existing information on drug, device or biological constituents and by ensuring that development tests are focused on the critical safety and effectiveness issues raised by the combination product.” 2. Facilitate the development of devices in critical areas of unmet needs, such as pediatrics. “Such research includes developing anatomically and physiologically accurate adult and pediatric virtual circulatory systems that can quantify the maximum load and stress forces for certain vascular stent devices.” Other examples include developing animal models to improve prediction of toxic effects of medical products on critically ill patients, as well as a new statistical model for predicting the effectiveness of implanted cardiac stents. 3. Facilitate communication among the FDA, manufacturers, clinicians and the public about devices being developed and those that have recently been cleared for marketing. 4. Step up its internal laboratory research on ways to expeditiously test new technologies. Examples include study on experimental and computational fluid dynamics to evaluate a pediatric cardiac device, as well as the agency’s development of new models and methods for the assessment of computer-assisted diagnostic systems. 5. Implement a quality review program for the benefit of FDA and manufacturers. The goal is to ensure consistency among the agency’s reviewers and to help manufacturers “submit applications that efficiently demonstrate the safety and effectiveness of the device,” says FDA. 6. Remain current on the latest technological and clinical advances by hiring outside experts. Over the past two years, the agency has hired experts in many critical areas, including anesthesiology, brachytherapy, cardiothoracic surgery, electrophysiology, human factors engineering, neurosurgery, nephrology, pediatric cardiology, pulmonology, radiation oncology and software engineering, says the agency. “These experts will help FDA expedite the availability of new, cutting edge technology.”
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