FDA Week - 05/18/2018

The House Appropriations Committee approved Wednesday (May 16) a fiscal 2019 FDA spending bill, and in the process tacked on a controversial tobacco amendment that several Democrats and one Republican argued would essentially rewrite the Tobacco Control Act and weaken FDA's ability to regulate tobacco products, especially e-cigarettes and cigars that appeal to youth.

The House will vote next week on the Right to Try bill passed out of the Senate last August, House leadership said Thursday. The move has the support of FDA Commissioner Scott Gottlieb, as well as House Energy & Commerce leadership, which previously argued the bill had problems that if not fixed would make the measure less effective for patients.

HHS Secretary Alex Azar is explaining why the president's newly released drug pricing plan doesn't deliver on two of President Donald Trump's campaign promises: direct drug price negotiation in Medicare and allowing importation of cheaper drugs from Canada. Azar argued that both proposals were left out because they don't work, and while he dismissed importation outright, he argued that Trump's plan will actually increase price negotiation in Medicare, just not the way both Democrats and Trump had pushed.

FDA Commissioner Scott Gottlieb said Tuesday (May 15) that the upcoming guidance on waiving the requirement that brands and generics share a safety system will be short and simply put brands on notice that FDA is ready, willing and able to waive the requirement when it is blocking generic competition -- despite an earlier prediction from a policy watcher close to the issue that the guidance would lay out specific steps each party must go through before FDA can waive the requirement.

FDA soon will announce a set of reforms intended to make the new drug approval process more efficient and spur innovation, FDA Commissioner Scott Gottlieb told reporters during a Monday (May 14) media briefing. The agency chief pointed to gene therapies that are therapeutically equivalent to each other as having the potential to increase competition and negotiating power when it comes to prices.

FDA on Wednesday (May 16) approved US WorldMeds LLC's Lucemyra, the first agency-approved non-opioid treatment for mitigating the symptoms of opioid withdrawal. Lucemyra, FDA noted, is only approved for treatment up to 14 days and is to be used as part of a broader, long-term treatment plan for managing opioid use disorder. The agency also is requiring 15 additional postmarketing studies to assess longer-term use and use in children and newborns.

HHS Secretary Alex Azar on Wednesday (May 16) hit back at the drug industry for criticizing the administration's proposal to move Medicare Part B drugs into Part D, and he said the announcement on how HHS will execute that policy is coming soon. He also warned that killing the administration's proposal will keep alive efforts to let the government negotiate prices.

Rep. Elijah Cummings (D-MD), who met with President Donald Trump earlier in his presidency to push for Medicare price negotiation, appears to have given up on working with Trump -- releasing a report Friday (May 11) outlining what he sees as the president's failure to constrain drug prices.

A Pharmaceutical Research and Manufacturers of America executive on Tuesday (May 15) criticized several policies that HHS is considering to lower drug costs: moving Medicare Part B drugs to Part D, replacing the Part B doctor-reimbursement system with the Competitive Acquisition Program, encouraging plans to restrict the use of drugs in protected classes, removing the two-drug per-class rule in Part D, basing Medicaid's average manufacturer price calculation on commercial-market net prices and removing the cap on price-inflation penalty in Medicaid.

HHS Secretary Alex Azar said CMS will take a more permissive approach to the performance scores it gives drug plans that use medication management tools for drugs in Part D's six protected classes. The Obama administration was attacked by patients, drug makers and both political parties for proposing to remove the protected status of three of those drug classes, but Azar said the Trump administration's proposal would merely let plans take advantage of existing medication management tools that they fear employing. However, CMS is at least considering withdrawing protected status of drugs when companies raise prices aggressively, according to a request for information that CMS issued Monday (May 14).

President Donald Trump's drug price containment plan blames the 340B drug discount program in part for high drug prices, and asks for feedback in a number of areas including how the program's growth affects list prices and insurers, whether the definition of a 340B patient should be changed and how to better prohibit duplicate discounts.

CMS' Medicare Evidence Development & Coverage Advisory Committee will meet in August to consider a National Coverage Determination for chimeric antigen receptor (CAR)-T cell therapies after UnitedHealthcare requested such a determination to make sure there is a level playing field across Medicare for coverage of the expensive therapies.