Amneal launches first Mephyton generic
Amneal Pharmaceuticals announced on Tuesday the launch of Phytonadione Tablets, USP, 5 mg, the first AB-rated therapeutic equivalent for Mephyton.
The product is available in 100-ct bottles and is now shipping to wholesalers, distributors and direct to the trade.
“We are extremely pleased to bring the first generic alternative for Mephyton to market,” stated Andy Boyer, executive vice president of Commercial Operations for Amneal. “It’s always rewarding to provide the healthcare system with new generics that provide lower cost alternatives and open the door for further competition.”
Annual U.S. sales of the blood-clotting drug were $106 million, according to March 2018 IQVIA market data.
AAM praises generics’ role in Trump pricing plan
In a move that’s considered an “important step forward for patients coping with skyrocketing health care costs,” Association for Accessible Medicines president and CEO Chester “Chip” Davis, Jr., praised President Trump for making clear in his remarks on Friday the important role that generic and biosimilar medicines play in containing prescription drug costs for patients.
“President Trump’s embrace of generic and biosimilar competition as a key to lowering brand-name drug prices is an important step forward for patients coping with skyrocketing health care costs,” said Davis. “Patients will benefit most from meaningful initiatives that ensure robust competition and timely access to these life-saving medicines.”
Davis also enumerated in a blog post specific ways the president can enhance generic and biosimilar competition to provide patients with relief from the high prices of brand-name drugs.
In addition to the president’s speech, the administration and its health care policy officials recently have provided briefings and remarks giving a more complete understanding of the direction of their plan to lower drug prices. The outline given by the president and the administration includes:
- Increasing market-based competition for more generic and biosimilar medicines;
- Combating branded pharmaceutical company “shenanigans” with FDA’s safety rules;
- Highlighting branded pharmaceutical company gaming of the patent system to extend monopolies; and
- Eliminating co-pays for generics and biosimilars for low-income seniors in Medicare Part D.
The president announced that his administration is seeking input. A formal Request for Information is being issued and AAM will submit comments.
“Manufacturers of generic and biosimilar medicines look forward to working with President Trump, Secretary Azar and the entire administration to ensure these safe, effective, FDA-approved therapies are accessible to patients so they may find relief from the high prices of brand-name drugs,” Davis said.
Iowa Gov. Kim Reynolds signs bipartisan opioid bill into law
NACDS applauds enactment of House File 2377
DUBUQUE, Ohio — In an effort to battle the opioid epidemic, Iowa is tackling the issue of doctor shopping and over-prescribing in the state with a bipartisan piece of legislation signed Monday by Gov. Kim Reynolds.
Reynolds said House File 2377 represents a significant step forward in Iowa’s efforts to address the opioid epidemic. The governor signed the bill in front of overdose victims’ families, law enforcement, state and local officials and others at Mercy Medical Center in Dubuque.
“Opioid-related deaths have more than doubled over the past decade,” said Reynolds. “And like I said in my Condition of the State address, this will not end until we take action. With this legislation, we are taking the first step to reverse this heart-wrenching trend.”
House File 2377 helps prevent doctor shopping and over-prescribing by:
- Requiring all prescribers to register for and use the prescription monitoring program;
- Allowing for proactive notification to recognize patients at high risk for abuse and addiction;
- Requiring electronic prescribing in order to eliminate the risk of fraud; and
- Allowing licensing boards to assess penalties for providers who over prescribe.
House File 2377 also aims to take a “compassionate” approach to ensure those who need immediate help with an overdose receive it by providing for immunity from criminal liability for those who call 911 to seek care for someone who has overdosed on drugs.
The opioid bill passed the Iowa Senate on April 30, 48-0 and the Iowa House on May 2, 95-0.
The state’s move to require e-prescribing, effective Jan. 1, 2020, drew praise from NACDS.
“Governor Reynolds and the leadership of the Iowa Senate and of the Iowa House of Representatives have taken decisive action on the opioid abuse epidemic by looking to electronic prescribing to help curb fraud, abuse and waste. The Iowa General Assembly’s Opioid Epidemic Evaluation Study Committee and the Iowa Board of Pharmacy deserve thanks as well for their engagement and leadership,” said NACDS president and CEO Steve Anderson in a statement issued Monday.
“NACDS also recognizes the Iowa Retail Federation and NACDS member companies for working hard to make the case for solutions to the opioid abuse epidemic, based on pharmacists’ experiences on the front lines of healthcare delivery,” Anderson added.
A poll conducted by Morning Consult and commissioned by NACDS in January 2018 found 75 percent of Iowa voters support a requirement that all prescriptions must be handled electronically, rather than via paper or fax, as a way to help address the opioid abuse epidemic. Reflecting a strong intensity of opinion, 44 percent of Iowa voters “strongly support” such a requirement — with strong support seen on a bipartisan basis and across political ideologies.
NACDS noted that the legislation is consistent with an array of public policy recommendations announced by NACDS, and with NACDS’ comments to the President’s Commission on Combating Drug Addiction and the Opioid Crisis.
At the federal level, NACDS has endorsed the Every Prescription Conveyed Securely Act (H.R. 3528 and S. 2460). The bill would require that Schedule II through V controlled substances for Medicare Part D beneficiaries are prescribed electronically.
“Together, federal and state actions will enhance the use of e-prescribing to help reduce fraud, abuse and waste of controlled substances. NACDS salutes Iowa’s leadership in this regard,” Anderson said.