with Paulina Firozi
As FDA commissioner, Scott Gottlieb can’t tell drug makers how much to charge for their products, unlike the top officials regulating the drug industry in many other developed countries. But when he was confirmed back in May, Gottlieb identified generics as the space where the agency could potentially have the most impact in the quickest way – both by making it easier for companies to develop generic drugs and nudging generics into markets with no existing competition.
“I think the greatest opportunity to have a very palpable impact on people’s lives is through trying to create greater access,” Gottlieb said in a recent interview with The Health 202. “The low-hanging fruit was on the generic drug side.”
Generics were also a priority for Gottlieb’s predecessor, Rob Califf, who was troubled by the massive backlog of generic drug applications, a list that reached longer than 2,800 pending applications in 2012. The backlog is now down to the low 100s, according to Gottlieb, but he wants to essentially eliminate it so companies can obtain immediate review once they apply.
Part of reaching that goal involves shortening the typical review period, which several years ago averaged as much as 31 months. The FDA has made strides since then, but Gottlieb says he’s aiming for an average review length of just 10 months.
At least in terms of its generic drug goals, the agency ended 2017 with a bang. In October, the FDA announced it had approved 763 generic drug applications so far that year, exceeding previous records of 651 approvals in 2016 and 492 approvals the year prior.
Last week, Gottlieb tweeted that generic approvals had exceeded 1,000 for 2017:
In a year where health-care policy could hardly have been more contentious on Capitol Hill, Gottlieb has received unusually rave and bipartisan reviews for his approach:
Andy Slavitt, former head of the Centers for Medicare and Medicaid Services under President Obama:
There’s no denying Gottlieb's a conservative who opposes government price controls – he most recently served as a fellow at the conservative think tank the American Enterprise Institute – but he says the government needs to do a much better job of promoting competition among drug makers.
“Companies sometimes go through very torturous processes to bring a generic drug onto the market,” Gottlieb said.
For example, the FDA has started prioritizing applications for generics where there’s just one competitor on the market. In June, Gottlieb instructed the FDA to publish and regularly update a list of approved drugs that are no longer protected by patents or exclusivity periods and have no generic competition – in other words, drugs that could be highly attractive to a generic developer.
The agency has promised to expedite review of applications for any drugs on this list, with an eye toward creating more generic choices for consumers who currently have access to only one branded option.
“Hopefully it will have some immediate impact,” Gottlieb said.
Gottlieb said he’s also trying to ease the ability of companies to prove their generic version of an already approved drug is the same as the branded drug they’re trying to emulate. Branded companies often game the system by making it hard for generic companies to buy the 2,000 to 5,000 doses of a drug they need to prove it’s the same makeup.
Gottlieb said he finds the practice so “pernicious” because it undermines the U.S. system of market-based drug pricing.
“We accept the prices, but the flip side of that is we have an expectation that there will be vigorous competition,” Gottlieb said.
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AHH: A federal judge is allowing the Trump administration to move forward with its planned $1.6 billion cut to the 340B federal drug discount program, Modern Healthcare reports.
Three major hospital groups -- the American Hospital Association, the Association of American Medical Colleges and America's Essential Hospitals -- are suing the Centers for Medicare and Medicaid Services to halt the planned cuts, which for them means major reductions in their drug reimbursements for Medicaid patients. But U.S. District Judge Rudolph Contreras ruled Friday the hospitals sued CMS prematurely, since the proposed cuts weren't going into effect until Jan. 1.
Arguing the cuts will threaten access to care for many low-income and vulnerable patients, the hospitals say they'll continue pursuing the lawsuit. But the judge insisted the associations' comments on the proposed rule weren't enough to give them standing to sue, saying they'll have to cite specific reimbursement claims in order for a lawsuit to proceed.
OOF: If you read The Health 202 regularly (or even occasionally), you're probably aware that Republicans repealed only a single part (the individual mandate) of the massive, multi-pronged 2010 health-care law in their tax bill. Of course that didn't stop President Trump from claiming to have repealed Obamacare -- and about one-third of Americans believe him, a new poll shows.
Thirty-one percent of respondents to an Economist/YouGov poll agreed that Trump kept his campaign promise to repeal the Affordable Care Act. Those most likely to believe Obamacare has been repealed include those over age 64 (38 percent) and those who vote Republican (44 percent). Just 49 percent of those polled answered correctly that Trump largely hasn't kept his promise to repeal the ACA.
OUCH: The AP's Sadie Gurman offers a fascinating report on how the Justice Department is making available reams of new data available to help sniff out the nation's top opioid prescribers. The October indictment of top opioid prescriber Andrzej Zielke was the first by a nationwide group of federal law enforcement officials that, armed with new access to a broader array of prescription drug databases, Medicaid and Medicare figures, coroners’ records and other DOJ data, aims to stop fraudulent doctors faster, Sadie writes.
"The department is providing a trove of data to the Opioid Fraud and Abuse Detection Unit, which draws together authorities in 12 regions across the country, that shows which doctors are prescribing the most, how far patients will travel to see them and whether any have died within 60 days of receiving one of their prescriptions, among other information," Sadie writes.
"Authorities have been going after so-called 'pill mills' for years, but the new approach brings additional federal resources to bear against the escalating epidemic," she continues. "Where prosecutors would spend months or longer building a case by relying on erratic informants and only limited data, the number-crunching by analysts in Washington provides information they say lets them quickly zero in on a region’s top opioid prescribers."
“This data shines a light we’ve never had before,” longtime federal prosecutor Robert Cessar told Sadie. “We don’t need to have confidential informants on the street to start a case. Now, we have someone behind a computer screen who is helping us. That has to put (doctors) on notice that we have new tools.”
--The White House has dismissed the remaining members of the Presidential Advisory Council on HIV/AIDS, a few months after a half-dozen members resigned to protest the administration's health-policy positions, The Post's Ben Guarino reports. A form letter sent to remaining members thanked them for their service and said their appointments were terminated immediately, according to Emory University's Patrick Sullivan, who was appointed to a four-year term May 2016.
The council, which has advised the White House on HIV/AIDS policies since its founding in 1995, offers recommendations on the National HIV/AIDS Strategy, a five-year plan responding to the epidemic. The council's executive director, Kaye Hayes, confirmed in a statement that all remaining 10 council members had received the termination letters last Wednesday.
“Changing the makeup of federal advisory committee members is a common occurrence during administration changes,” Hayes said in the statement. “The Obama administration dismissed the George W. Bush administration appointees to PACHA in order to bring in new voices. All PACHA members are eligible to apply to serve on the new council that will be convened in 2018.”
But former council members said previous administrations allowed members to serve full terms before appointing replacements. “It is important to have a rolling, transitioning body that crosses administrations that really has a set of diverse outlooks on the epidemic,” Sullivan said.
--Trump will undergo a physical exam next week, in his first publicly known medical checkup by a government doctor since becoming president. He'll be examined Jan. 12 by Rear Admiral Ronny Jackson, the physician to the president, at Walter Reed National Military Medical Center in Bethesda, per Bloomberg. After the examination, Jackson will issue a public statement about Trump's health.
The White House first announced a physical would be scheduled for the president earlier this month, after he appeared to slur words during a speech announcing the United States would recognize Jerusalem as the capital of Israel. While the incident prompted some speculation about Trump's health, White House press secretary Sarah Huckabee Sanders dismissed the concerns as "ridiculous."
--Yesterday, recreational marijuana became legal for adults over 21 in California -- but resident still aren't able to buy pot everywhere as businesses struggle through red tape to be allowed to sell it, The Post's Katie Zezima reports. "Along the way, an edgy, sexy industry has become beholden to reams of regulations and compliance issues — in other words, marijuana has become just another business in California," Katie writes. "The change has not been easy, and some feel in limbo as the cannabis industry, which has been valued at between $5 billion and $7 billion, starts to take form."
For example, businesses must comply with regulations from the state and the city or county where they operate, and the localities have instituted different rules on where businesses can locate, what signs and security are required and how many businesses are allowed in town. In San Diego, which has fully embraced the marijuana business, facilities must be at least 1,000 feet from parks and child-care facilities. Neighboring National City has banned all cannabis businesses. Los Angeles requires video surveillance of businesses.
"Many involved believe it will be several months before the market starts to settle and availability will become much more widespread. The regulations will, in many places, continue to be tweaked," Katie writes. "In some places, when business owners ask cities about their cannabis regulations, there are no answers."
“We’re building an airplane while we’re flying it,” said state Sen. Mike McGuire (D), who represents the northern coastal region of California, where many marijuana farms are located.
California has issued about 200 permits for a variety of uses, including retail stores, although more than 1,185 licensing applications have been submitted. As for municipalities, some haven't even finalized the regulations needed for a marijuana business to open. "They have been accused of dragging their feet or making it difficult for those looking to enter the business to figure out how to follow the rules," Katie writes.
--Welcome back to town, senators. The upper chamber resumes its business on Wednesday, while the House enjoys one more week of recess.
Get ready. Congress faces a jam-packed to-do list this month with deadlines looming on a government shutdown and a number of big, outstanding health-care policies -- the fate of two marketplace stabilization bills and long-term funding for the Children's Health Insurance Program, which lawmakers have essentially punted until the end of March.
"Fresh off a party-line vote in favor of legislation overhauling the tax code, the negotiations will test whether Congress and the White House still have the potential to craft any form of bipartisan agreement," The Post's Jeff Stein writes. "If not, the government could soon be on the verge of a shutdown, with pressing questions regarding health care, immigration and other policies left unresolved."
“I’m not sure I’ve seen anything like it, at least in recent years, where so much high-profile stuff has to be done right out of the gate," Jim Manley, former aide to Senate Majority Leader Harry Reid, told Jeff.
--We'd venture to guess President Trump's New Year's resolutions didn't include being more truthful. When The Post's fact-checker Glenn Kessler combed through the transcript of an impromptu 30-minute interview the president gave last week to the New York Times, he found 24 false or misleading claims. Below, we're highlighting Trump's health-care-oriented statements and Glenn's explanation.
Trump: “By the way, and for that, we’ve ended across state lines. So we have competition. You know for that I’m allowed to [inaudible] state lines. So that’s all done.”
The reality: Trump signed an executive order encouraging the formation of health plans across state lines. But there is still a law in place that exempts insurance companies from aspects of federal antitrust law and ensures that individual states remained the primary regulators of insurance.
Trump: “I know the details of taxes better than anybody. Better than the greatest C.P.A. I know the details of health care better than most, better than most.”
The reality: Lawmakers who dealt with Trump on taxes and especially health care privately told reporters they were shocked how little he knew about these issues.
Trump: “We’ve created associations, millions of people are joining associations. Millions. That were formerly in Obamacare or didn’t have insurance. Or didn’t have health care. Millions of people.”
The reality: Trump is referring to an executive order, mentioned above, but it has no force in law on its own and no one has yet joined these associations. The rules spelling out how the executive order would work have not been issued yet, so Trump is simply making up his “millions” number.
Trump: “Now that the individual mandate is officially killed, people have no idea how big a deal that was. It’s the most unpopular part of Obamacare. But now, Obamacare is essentially … You know, you saw this. … It’s basically dead over a period of time.”
The reality: While the individual mandate was an important incentive for Americans to seek health insurance, it was only one part of a far-reaching law that remains intact. The repeal does not take effect until 2019, and enrollment in Obamacare has remained strong. The Congressional Budget Office says the marketplaces are expected to remain stable for years.
Trump: “We see the drugs pouring into the country, we need the wall.”
The reality: The wall will have virtually no effect on drugs coming into the country. According to reports by the Drug Enforcement Administration, the majority of drugs are smuggled through legal ports of entry or smuggled through underground tunnels. Trump previously earned Four Pinocchios for this claim, but he keeps saying it.
- The American Enterprise Institute holds a discussion on "Reconnecting Health Care Policy with Economics: Finding and Fixing Distortive Incentives” on Thursday.
- The Senate Health, Education, Labor and Pensions Committee holds a hearing on the opioid crisis on Jan. 9.
- The House Veterans’ Affairs Subcommittee on Economic Opportunity holds a hearing on "Home Loan Churning Practices and How Veteran Homebuyers are Being Affected” on Jan. 10.
- The National Academy of Sciences holds a workshop on "The Promise of Genome Editing Tools to Advance Environmental Health Research” on Jan. 10-11.
- The House Veterans’ Affairs Subcommittees on Health and on Economic Opportunity hold a joint hearing on addressing veteran homelessness on Jan. 18.
See Wolf Blitzer "sing" the top hits of 2017:
Watch President Trump and his family celebrate New Year's Eve at Mar-a-Lago: