US Senate Passes FDA User Fees, Right to Try and Opioid Legislation
After many months of debate, both chambers of Congress passed the FDA User Fee Package. This comes after the Senate passed its bill (S. 934) which cleared the Senate HELP Committee in May on a bipartisan basis. The House passed its bill on July 13 (H.R. 2430). The FDA Reauthorization Act (FDARA) renews and enhances the FDA drug, medical-device, biosimilar, and generic-drug user-fee provisions. The bill was uniquely tied to “Right to Try” legislation, and the Senate also passed bipartisan legislation on the opioid epidemic.
Senate FDARA Bill
The politics of the bill were intricately locked in with another member of th...
Source: Policy and Medicine - August 3, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Celgene Settles Cancer Drug Whistleblower Suit
Celgene Corporation has settled a whistleblower lawsuit for $280 million, alleging that the pharmaceutical company committed fraud promoting Thalomid, a cancer drug allegedly promoted for uses not approved by the United States Food and Drug Administration (FDA). The settlement will be broken up between the United States and twenty-eight states and Washington, D.C. California will receive the largest state sum, $4.7 million.
The payment is equivalent to about two weeks’ worth of sales of Revlimid, which generated $6.97 billion in revenue for Celgene last year, according to data compiled by Bloomberg.
The settlement, ini...
Source: Policy and Medicine - August 3, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Opioid Commission Interim Report - Calls for Mandatory CME for Opioid Prescribers
The White House’s Commission on Combating Drug Addiction and the Opioid Crisis (Opioid Commission) has issued an interim report, which offers recommended actions for President Trump to take now, with more recommendations planned for the fall of 2017. The headline-creator of the report was the recommendation to President Trump that he declare the opioid epidemic a national public health emergency and expedite funds and resources to stop the crisis.
The Opioid Commission discussed its outreach to individuals and organizations, including all fifty Governors and bipartisan members of Congress, providers, insurers and medica...
Source: Policy and Medicine - August 2, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Mallinckrodt Settles Anti-Competitive Practices Suit
Mallinckrodt and the Federal Trade Commission (FTC) recently agreed to settle allegations of raising drug prices and engaging in anti-competitive practices by paying a $100 million fine and allowing a competitor to produce a similar medication. The drug, H.P. Acthar Gel, is used to treat infantile spasms and multiple sclerosis. Mallinckrodt allegedly raised the price of the prescription from $40 per vial to over $34,000 per vial.
According to New York Attorney General Eric Schneiderman’s office, Mallinckrodt’s United States subsidiary (Questcor) purchased the drug in 2001 and raised the price an estimated 85,000% over...
Source: Policy and Medicine - August 1, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Punting on the Issue of FCA and Statistical Sampling
In a much-anticipated U.S. Court of Appeals decision, the Fourth Circuit on February 14, 2017, in evaluating the issue of whether the government has veto power over False Claims Act (FCA) settlements, particularly where liability is established by use of statistical sampling, opted to forego rendering a decision on such issue, and leaving wide open the use and appropriateness of statistical sampling in FCA related cases.
In May of 2016, we briefly highlighted the case of United States ex rel. Michaels v. Agape Senior Cmty., Inc. It was case involving a qui tam action that alleged a network of “twenty-four nursing homes ...
Source: Policy and Medicine - July 31, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Canadian Health Minister Considering Forced Transparency
We recently wrote about ten Canadian pharmaceutical companies that are voluntarily disclosing payment amounts to the general public. Now, the Ontario Health Minister, Eric Hoskins, is thinking about mandating that pharmaceutical companies disclose payments made to doctors.
He made the announcement in mid-June, and will hold consultations before making any decision. Hoskins applauded the earlier voluntary transparency decision made by the ten Canadian companies, noting that “Our system is strongest when patients and the public have access to appropriate information so they can make informed decisions about their health c...
Source: Policy and Medicine - July 31, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Pharmaceutical and Device Manufacturers: Buyer Seller Beware
Pharmaceutical and medical device manufacturers continue to face intense scrutiny from regulatory and enforcement agencies, as well as whistleblowers seeking large payouts for disclosing potential wrongdoing. There are a number of risk areas (some new, some not-so-new) that provide the basis for the government and relators to pursue alleged violations of the False Claims Act liability. Some of those areas are discussed below.
Pharmaceutical and medical device manufacturers continue to be on the radar of government enforcers and whistleblowers. In particular, the government’s False Claims Act (“FCA”) enforcement eff...
Source: Policy and Medicine - July 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Orphan Drug Modernization Plan Released
In late June 2017, the U.S. Food and Drug Administration (“FDA”) unveiled a strategic plan to both eliminate the agency’s existing orphan designation request backlog and ensure timely responses to all new requests for designation with firm deadlines.
This Orphan Drug Modernization Plan comes hot on the heels of FDA Commissioner Scott Gottlieb’s testimony before a Senate subcommittee, where he made a commitment to (1) eliminate the current backlog within ninety days and (2) respond to all new requests for designation within ninety days of receipt.
Authorized under the Orphan...
Source: Policy and Medicine - July 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Large Canadian Drug Companies Begin Voluntarily Disclosing Information
Ten well-known drug companies in Canada have started to voluntarily disclose how much money they pay to physicians, hospitals, and health care groups, with the information posted on their websites. The ten companies participating in the voluntary disclosure are: GlaxoSmithKline, Amgen, Bristol-Myers Squibb, Gilead, Eli Lilly, Merck, Novartis, Purdue, Roche, and AbbVie Corp.
There are three different categories that the voluntary disclosure covers: fees for health care professional services/transfer of value to Canadian health care professionals; funding to health care organizations; and sponsorship of Canadian health care...
Source: Policy and Medicine - July 27, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
LSCU SPECIAL FEATURE: Into the Nexus - Anti-Kickback Statute ( " AKS " ) versus Value-Driven Health Care
Part 2: The Tension Increases - Online Auctions Violate the AKS
We have noted in previous articles that there is an increasing tension between efforts to reduce healthcare costs and assuring those efforts are not improper inducements under the Anti-Kickback Statute’s (“AKS”). In a recent opinion by the Federal District Court in Connecticut, that tension ratcheted up several notches with the Court’s novel application of the AKS to certain e-commerce arrangements.
The decision in Medpricer.com, Inc. v. Becton, Dickinson & Co was originally decided in March 2017 and reaffirmed in April. Judge Michael Shea’s ...
Source: Policy and Medicine - July 26, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Ontario Enters the Transparency Spotlight
Over three years ago, the Toronto Star filed a freedom of information (FIPPA) request with the Health Ministry in Ontario, Canada, seeking physician-identified data on the top 100 billers. Last year, the information and privacy commissioner ordered the disclosure of the top billers’ identities, along with amounts each receives in payments from the taxpayer-funded insurance plan.
The Health Ministry allowed partial access to the Star, including payments and most medical specialties, withholding physician names. The Ministry withheld the names as it determined releasing the names would be an “unjustified invasion of pri...
Source: Policy and Medicine - July 26, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
New Report Releases Strategies to Reduce Opioid Epidemic
The National Academies of Sciences, Engineering, and Medicine recently released a report, requested by the United States Food and Drug Administration, that highlights what can be done to stop the opioid use disorder and other opioid-related harms without closing access to opioids for patients who need them.
The committee that conducted the study and wrote the report recommended actions the FDA, other federal agencies, state and local governments, and health-related organizations should take – which include promoting more cautious prescribing of opioids, expanding access to treatment for opioid use disorder, preventing m...
Source: Policy and Medicine - July 25, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
LSCU SPECIAL FEATURE: Into the Nexus - Anti-Kickback Statute ( " AKS " ) versus Value-Driven Health Care
Part 1: An Uncertain Future in a Dynamic Landscape
Fans of Star Trek will remember the scene from the 1994 movie “Generations” in which Captains James T. Kirk and Jean-Luc Picard meet each other in The Nexus: the old versus the new. As the need to reform the healthcare system becomes ever more urgent, a new Nexus has developed between the old legal and regulatory framework (i.e., the Anti-Kickback Statute) and new ways of incentivizing the system to reward improved patient outcomes (i.e., Value Driven Health Care).
Health care is changing, including the way in which payments, compensation, and value policies an...
Source: Policy and Medicine - July 24, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
AAFP and ABFM Collaborate to Create Unified Credit Reporting Process
Earlier this month, the American Academy of Family Physicians (AAFP) announced a collaboration with the American Board of Family Medicine (ABFM) to create a more seamless credit-reporting experience for family physicians. The new process will allow AAFP members to use the AAFP as a one-stop shop for all of their Continuing Medical Education (CME) credit reporting needs.
It is hoped that this new process will make it easier for providers to claim their credit for performance improvement CME activities with both the AAFP and the ABFM.
The AAFP – as one of the nation’s three CME accrediting bodies – will work with CME...
Source: Policy and Medicine - July 24, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Hearing on Innovation and Access
Discussion
Academic Perspectives
Researchers and academics focused heavily on increasing competition through: reforming REMS regulations; addressing harms from citizen petitions; and brand pharmaceutical marketing practices.
Michael Carrier, an expert in the pharmaceutical industry and antitrust laws at Rutgers Law, stated that certain actions by brand companies distort the Hatch-Waxman Act to evade the system and impede entry of generics to the market, and that these actions “are not about innovation.” FDA panelists were interested in how to prospectively address the approximately 20 percent of reformulations, or ...
Source: Policy and Medicine - July 21, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
