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MENU LABELING GUIDANCE MIA AS DEADLINE APPROACHES: As of Monday, restaurants, grocery stores, movie theaters - and all other chains serving "restaurant-type food" - will have to post their calories on their menus. But these businesses are also anxiously awaiting final guidance from FDA to give them more details on how to comply with the rule.
FDA Commissioner Scott Gottlieb told POLITICO this week that the finalized guidance would be out soon - or more specifically "before or on" the compliance date (which is still Monday, after eight years of rigmarole).
While that's certainly a tight timeline, the commissioner emphasized that FDA is planning to spend the first year largely educating companies about compliance. "It wasn't like we were going to flip a switch on Monday and send out a bunch of warning letters," he said.
Retailers seek enforcement guidance: The Food Marketing Institute and other retail groups appear to be aware of this, but are worried that state and local officials will enforce labeling as they see fit. "We plan to make FDA and Congress aware of any enforcement prior to the conclusion of this 'education period' and provide our legal team to help with any challenges you face," FMI said in a blog post for members this week.

"We want FDA to come up with some guidance and set some parameters on enforcing," Jennifer Hatcher, chief public policy officer and vice president of government affairs, tells MA. "We want a consistent way of enforcing." [Politico’s Morning Agriculture, May 4, 2018]



GAMES & SPORTS






Vista Outdoor, a sports and recreation product manufacturer, hired Sorini, Samet & Associates to lobby on the Trump administration's Section 301 tariffs on imports from China. Ron Sorini, who was chief textile negotiator at the Office of the U.S. Trade Representative under President George H.W. Bush, will lobby on the issue, along with Megan Costello and Daniel Neumann [POLITICO Influence, May 7, 2018]



HEALTHCARE




TRUMP TO TALK DRUG PRICING, BUT WILL HE BREAK NEW GROUND? - All eyes are yet again on President Donald Trump as he prepares to deliver his first major address on drug pricing ... soon. Reports over the weekend of a second delayhad the address pushed back to Friday or possibly later, even as observers began predicting a meatier speech than they had first anticipated. ("Pharma's Brave New World," Wells Fargo analysts headlined a note that did not even reference the president's speech.) The big talk, at least initially, was expected to coincide with a separate speech by HHS Secretary Alex Azar on his own detailed vision for how the country should attack the rising cost of drugs.
Though the White House has offered a slew of proposals on how it wants to tackle the topic - most notably in its fiscal year 2019 budget proposal in February - they were prepared before Azar took over the department, so this is the former pharmaceutical executive's chance to put to his imprint on the agenda. The speeches were originally scheduled for late April but were postponed, first as Azar battled an infection and second due to a reported scheduling conflict. Few predicted originally that the administration would break much new ground - or take steps that hit brand-name drugmakers' bottom line. Trump has been vigorously attacking the industry since his 2016 campaign, but has shown few signs of following through.
"I am not expecting much that will actually lower costs," John Rother, president and CEO of the National Coalition on Health Care - whose membership includes health insurers, doctor groups and labor organizations, among others - said a couple weeks ago. "What we've seen before is more about cost-shifting," he said, referencing an idea CMS has been considering that would require Medicare Part D insurance plans to share directly with patients the rebates they get from drugmakers on certain medicines. The move could help some patients but wouldn't address what companies charge - or the cost of drugs themselves.
But sentiment began shifting late last week: Azar said Wednesday that Trump wants the forthcoming drug pricing plan to go further than the February budget document. And FDA Commissioner Scott Gottlieb suggested Thursday that the government re-examine regulations that shield drug rebates from antitrust scrutiny.
Those speeches "increase the uncertainty and show a willingness by the administration to get more aggressive," Evercore ISI's Ross Muken and Michael Newshel wrote in a note to clients.
Previous CMS proposals suggested the administration was looking at changes to the Medicare Part D rebate system - a change, but one that would leave the current system "basically intact," the Evercore health analysts wrote. "But now it appears more meaningful disruption is possible."
Add a haunting note from Wells Fargo: Pharma analysts at Wells Fargo on Thursday suggested a bleak future for the drug industry. "We believe the U.S. is on a longer-term arc toward price controls and lower margins, as there is an uprising that has been percolating for years against high drug prices. While the causes are many and the problem much more complicated and nuanced than many others would lead readers to believe, there is a rebellion at hand," David Maris and colleagues wrote.
The Wells Fargo analysts also worried that the industry has not seen this "trouble brewing." What kind of trouble? "We worry that some may be living in a bubble, a cozy patent-protected, high margin bubble, mesmerized by the bubble's beautiful swirling iridescence," they wrote.

What to listen for in Trump's speech:
- Will the president's address align with the more formalized policy that HHS is working on, or will he go off-script? Trump may not even stick to the topic at hand. What policies result from any off-the-cuff remarks is anyone's guess.
- The White House has said to expect formal requests for information and has pointed to the 2019 budget proposal as a guidepost. There's a lot of anticipation among lobbyists that the administration will zero in on the idea of having private insurance companies negotiate the costs for certain drugs in Medicare Part B, similar to how the Medicare Part D outpatient drug program works. Currently, Part B medicines are reimbursed based on a fixed formula that allows drug companies to set their prices. The thinking on K Street is that this would be done through a CMS Innovation Center demonstration, but one that avoids the controversy that quickly killed the Obama administration's part B demo idea - voluntary, and with parameters intended to avoid immediate pushback. Look for possible RFIs related to Medicaid and the 340B drug discount program as well.
- How will FDA fit into the mix? While Gottlieb has been pushing hard to increase market competition by calling out tactics that brand-name drug companies use to hold back generics, it will be interesting to see if Azar - his boss - or Trump elevates the FDA commissioner's ideas. Gottlieb has also said FDA is updating its guidance on biosimilars to "create a lower hurdle" for companies to demonstrate interchangeability with the branded biologic. That's one move the brand manufacturers aren't thrilled about.
- Congressional reaction: While the president's focus is expected to be on administrative solutions - not pressuring Congress to act - lawmakers still will have opinions. Buy-in from the House and Senate can be key to getting administration actions off the ground, even if they don't technically require lawmakers to sign off. Congress played a big part in killing the Obama administration's Part B drug demo, for instance. [POLITICO's Prescription Pulse, May 7 2018]



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NOTE: The news sources here vary.  Not all sources have the same credibility, but in an effort to share some different perspectives, they are included here.  This compendium itself cannot claim to be unbiased.  Please take into consideration where these different perspectives originate in assessing their value.  Thank you
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