Pets can be so cute when they gaze up at us with those wide puppy-dog eyes. But what if those eyes were bloodshot or droopy? As more states legalize marijuana and the cannabis industry grows, the ASPCA’s Animal Poison Control Center is seeing calls about marijuana ingestion skyrocketing – 765% in 2019 to be exact. THC can have a variety of effects on animals, from disorientation to hyperactivity, or in rare cases, seizures or even a coma. While mostly dangerous for pets, there are a handful of studies that show CBD may help with a variety of conditions including seizures, arthritis and cancer pain. However, similar to CBD for humans, most experts say more research is needed to see if it is safe and effective for pets. Our cats will be sticking to their Blue Buffalo diet while we take a look at the week’s news. | THE WEEK THAT WAS | Monday |  The U.S. House of Representatives unanimously passed two bills to increase transparency about the rebate system. The policies require the publication of aggregate rebate data from Medicare and ACA exchange plans on a drug-class level and give independent congressional agencies, Medicare Payment Advisory Commission (MedPac) and The Medicaid and CHIP Payment and Access Commission (MACPAC), access to drug pricing and rebate data to help Congress better understand the market. Days later, we got a better idea of just how much PBMs are getting in rebates. Cigna, which owns Express Scripts, says it is owed $4B from drug makers as of the end of Q3.
| Tuesday |  Have a headache? If it’s a side effect of an investigational new drug (IND), you may soon have to report it a different way. On Tuesday, the FDA issued draft guidance requiring clinical trial sponsors to submit IND safety reports for serious and unexpected adverse events to their Adverse Event Reporting System (FAERS) database. Currently, sponsors are required to submit IND safety reports to the FDA via a standardized form that is received either in paper format or electronically as a PDF. Streamlining submissions through FAERS will better allow the FDA to review and track safety signals pre and post-marketing.
| Wednesday |  The Centers for Disease Control and Prevention (CDC) released its 42nd report on the health status of the nation. Some interesting takeaways: the number of adults reporting taking 5 or more prescription drugs nearly doubled between 1999-2016 and 40% of American adults are now considered obese. We predict those prescription drugs may be for heart disease, diabetes and pain, as the risk for those conditions increase with obesity, but the report does not get that granular.
| Thursday |  A 73-year-old clinical trial participant at Massachusetts General Hospital became the first person to die from a fecal transplant. The unprecedented incident occurred in the spring, but new details emerged this week. It turned out the fecal capsules the man was taking as part of the trial contained a rare type of drug-resistant E. coli bacteria. The FDA is holding a meeting on Monday to discuss the safety and regulation of fecal transplants, including how donors are screened.
| Friday |  A new side effect of the measles is coming to light: “immune amnesia.” A study in Science reports that measles can destroy an average of 40% of antibodies that protect against other viruses and bacteria, leaving patients more susceptible to the flu, pneumonia, and other conditions for sometimes years. Experts hope this study encourages parents who are on the fence to get their kids vaccinated.
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|  No Shortage of Issues
By Michelle Leeds On Wednesday, the House Energy & Commerce Committee held a hearing on safeguarding pharmaceutical supply chains in a global economy, and the discussion included something for everyone! For our readers who didn’t want to watch the four hours of riveting testimony, here’s a recap of the hot topics discussed: - National security: The conversation took an ominous tone as the point was made over and over again that relying on overseas production can threaten access to drugs here in America (especially for critical drugs like antibiotics). Speakers noted that 90% of our active pharmaceutical ingredients (APIs) come from China and India. Rep. Anna Eshoo (D-Calif.), the panel's chair worried about our country’s vulnerability saying “if tensions with China escalate, Beijing could use U.S. dependence for critical drugs as an economic weapon and exploit the health and safety of our armed forces.”
- Bad Actors: Any conversation about China would be incomplete without someone noting that China employs both legal and illegal means of giving its companies an advantage in the global marketplace (i.e. subsidizing drug development, violating antitrust rules and stealing intellectual property).
- Drug shortages: The conversation turned at times to drug shortages and how they may relate to overseas manufacturing. FDA’s CDER Director Janet Woodcock testified that implementing advanced technologies like continuous manufacturing here in the U.S. can help combat drug shortages since companies can quickly ramp up production to meet demand.
- How are generic drugs made?: In an interesting exchange, Rep. Eshoo stated generic drug makers are “getting something for free” when they get the recipe for the branded drug and just remake it. A witness had to explain the reality that generic drug makers only get clinical data and then have to reverse engineer the formula on their own.
Our Take: Despite the emphasis on the threat to our national security, don’t expect any policy proposals on these issues in the near future. Drug makers should continue to educate policymakers about their commitment to patients and the safety of their manufacturing processes. And for generic drug makers, on top of communicating about cost savings, be prepared to explain even the most basic of concepts of how generics are developed and the investment that development requires.  Who wrote this? The managing editor of TWTW is Randi Kahn, who is disappointed that she wasn’t the one who came up with this excellent health policy themed Halloween costume. Syneos Health Communications' Reputation & Risk Management Practice is a team of healthcare communications consultants, policy-shapers and crisis response specialists. We provide unique solutions to the evolving communications challenges in today’s healthcare industry, using evidence-based approaches to help our clients successfully navigate the most sensitive of situations.
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