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Ron Lanton has over 20 combined years of government affairs and legal experience. This includes activities on the municipal, state, and federal levels of government. In addition to creating True North Political Solutions he has joined the Pharmacy Podcast Show as Government Affairs Strategist.... More
My company:
True North Political Solutions LLC
My blog:
True Trends Blog
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  • What's Behind The GMO Debate?

    What is the Story Behind the Genetically Modified Food Debate?

    Lately I have noticed several states debating genetically modified foods, so I decided to do some research. According to the United Nations, the world population is expected to reach 10 billion in the next ninety years. While much of this increase is expected to come from high fertility countries, more countries will be leaning on farmers to help meet this growing demand. Undoubtedly, this will lead to food cost increases but could science ease this expected supply strain?

    According to the World Health Organization, "Genetically modified organisms (GMOs) can be defined as organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally. A majority of commodity crops including soybeans, sugar beets, and feed corn are genetically engineered. The case can be made that GMOs are beneficial as they help reduce agricultural costs related to weeds, pests and crop disease. However; today's consumer is interested in knowing whether GMOs present long term health risks.

    In 1992 the Food and Drug Administration announced that genetically modified foods are generally regarded as safe. Additionally, the FDA established a voluntary process by which the producers could consult with the FDA about safety and regulatory issues prior to marketing. For years, critics of this policy continue to raise questions about safety and transparency for the consumer.

    While Congress and federal regulators continue to debate this issue, it seems as though New England is ground zero for deciding future GMO policies. In December, Connecticut became the first state to enact a GMO statute, albeit with a caveat. Rules from the law will only become effective until after at least four Northeastern states not including Connecticut with a combined population of no fewer than 20 million approve similar acts before it is officially enacted. Northeastern states are defined by the law as Maine, Vermont, New Hampshire, Massachusetts, Rhode Island, New York, New Jersey and Pennsylvania.

    Last month, Maine became the second state to enact GMO legislation. Similar to Connecticut, the bill has a caveat that the legislation will not go into effect until five nearby states including New Hampshire pass similar laws. As in Connecticut, the caveat seems to be in response to concerns about litigation from industry opponents as well as whether consumers who live in states that have enacted this legislation will be facing a competitive disadvantage. While GMO legislation has been introduced in Massachusetts and Rhode Island, Vermont currently seems to have the most momentum via H. 112. That bill is in currently in the Senate after passing the House last year. Legislation in New Hampshire was defeated last month.

    Both sides of this argument raise passionate points. The Coalition for Safe Affordable Foods which includes companies like Monsanto and Pepsi are opposed to GMO legislation. While they raise concerns about increased costs, a potential patchwork of state regulations that could cause supply chain inefficiencies along with possible confusion that labeling could cause, the Coalition believes that the FDA should be given authority to determine whether GMOs pose a health or safety risk. They would also like to see the FDA set federal standards for voluntary labeling and set a legal definition for the term "natural" on food and beverage labels.

    However; an increasing number of consumers are concerned about how GMOs will impact their health. According to a New York Times poll released on July 27, 2013, "Americans overwhelmingly support labeling foods that have been genetically modified or engineered, with 93% of respondents saying that foods containing such ingredients should be identified."

    While policy continues to be shaped, companies like General Mills, Ben and Jerry's, Chipotle, Kashi and Whole Foods have all taken proactive stances on GMOs by either eliminating them all together or pushing for increased labeling. It may be that the marketplace and the consumer's voice will be the deciding factors on future GMO policy after all.

    Mar 07 12:45 PM | Link | Comment!
  • Recently Enacted Congressional Legislation Will Impact Healthcare Supply Chain

    President Obama signed the Drug Quality & Security Act (H.R. 3204) into law on November 27, 2013. The law was created as a response to the meningitis outbreak from contaminated steroid pain injections that was traced to the New England Compounding Center in Framingham, MA. While many have focused on the law's compounding elements, the bill also sets forth pedigree provisions that the healthcare supply chain have discussed for years. Below are a few highlights of the bill:

    Compounding Summary: The bill allows the FDA to use a national standard while regulating facilities making adulterated, misbranded or unapproved products as well as allows the FDA to establish a list of drugs that may not be compounded for safety reasons. Compounders that mix sterile drugs without a prescription and ship across state lines can choose whether to register as an "outsourcing facility." The pharmacies that register would then be regulated by the FDA instead of a state board of pharmacy.

    The Secretary would be required to coordinate communication between the FDA and the state boards of pharmacy about any concerns against a compounding pharmacy. Additionally, the Government Accountability Office shall issue a follow-up report to Congress 3 years after enactment on the regulation of compounding pharmacies.

    Drug Pedigree Summary: This section sets forth drug tracing requirements for downstream pharmaceutical supply chain members including manufacturers, repackagers, distributors, and dispensers. Each time there is a change in ownership of a product, a document outlining the product's chain of custody must accompany the product. Once the product is serialized, manufacturers, wholesalers and repackagers must be able to respond to requests to verify the product at the unit level if there is suspect product at issue, while also being able to verify the product at unit level for saleable returns. Additionally, the legislation sets a 10 year timeframe for when supply chain entities must be compliant with the law. It also preempts state and local requirements related to drug pedigree and licensure of distributors and 3rd party logistics providers.

    Drug pedigree has been a contentious issue throughout the healthcare supply chain for over 25 years, with commitment to technological advances being the main holdup. It is still surprising to many industry insiders that regardless of Congress' divisive environment; such an important issue was addressed. It is even more surprising that it took a catalyst such as the unfortunate event in Framingham, MA to make this bill a reality.

    This information is useful if you are an investor seeking exposure to the healthcare industry via exchange traded funds such as the iShares Dow Jones US Pharmaceuticals Index Fund (NYSEARCA:IHE) or the SPDR S&P Pharmaceuticals ETF (NYSEARCA:XPH).

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Jan 12 11:54 PM | Link | Comment!
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