November 20, 2015

The Food and Drug Administration on Monday issued new warning labeling guidance for medicines containing acetaminophen, according to a blog posted by the Regulatory Affairs Professionals Society. "The guidance ... helps to clarify certain cases where manufacturers of internal analgesic, antipyretic and antirheumatic OTC drugs would be able to change liver warnings when the product's directions for use result in a maximum daily dose of acetaminophen that is less than 4,000 mg for adults," wrote Zachary Brennan. (RAPS

 

November 20, 2015

Specialty medications represent only 1% of all prescriptions but, in 2014, these medications resulted in over 31% of all drug spending.

November 19, 2015

With the 17th Annual NACDS Foundation Dinner rapidly approaching, the publicity surrounding the 2015 Get Smart About Antibiotics Week provides a timely demonstration of the public health relevance that the NACDS Foundation's benefactors will support on Dec. 3. 

November 18, 2015

Read about 8 of the various civil cases that the Department of Justice and Federal Trade Commission have brought against supplement makers or individuals. 

November 18, 2015

The Department of Justice announced the indictment of more than 100 manufacturers of illegal supplements as part of a yearlong effort that began last November. 

November 12, 2015

CQ Roll Call profiled NACDS’ VP government affairs in a piece ahead of the Nov. 16 ceremony for the Professional Women in Advocacy Conference’s Excellence in Advocacy award, for which Kelly is a finalist. 

November 11, 2015

Valeant Pharmaceuticals’ decision to raise the prices on a handful of drugs it has acquired over the past few years has led federal lawmakers and the Department of Justice to demand that the company explain its pricing policy.

November 11, 2015

A merger frenzy has hit the generics sector this year with a spate of acquisitions and hostile-takeover bids making headlines and reshaping the industry.

November 11, 2015

Rapidly rising prices for many generics, regulations that could restrict patients’ access to these medications, a Food and Drug Administration backlog in getting new drugs approved and market consolidation that is reducing competition are all making some wonder how much longer generics will continue to be affordable.

November 11, 2015

As 2015 draws to a close, the year is on track to be one in which the value of the branded drugs losing their patent protection approaches an all-time high. The dozens of drugs that will have lost their patent protection this year are estimated to have global sales of $44 billion a year — the highest total since $53 billion worth of medications went off patent in 2012.

November 10, 2015

New Jersey Gov. Chris Christie this week signed legislation allowing pharmacists to subsistute FDA-approved biosimilar products for biologics, and Generic Pharmaceutical Association voiced its support for the move. 

November 3, 2015
The Regulartory Affairs Professionals Society is reporting that as part of the recently passed budget deal that the president signed Monday, generics companies whose prices rise beyond the Average Manufacturer Price that’s adjusted for inflation will have to pay higher rebates. “The amount of the rebate specified in this paragraph for a rebate period, with respect to each dosage form and strength of a covered outpatient drug other than a single source drug or an innovator multiple source drug of a manufacturer, shall be increased in the manner that the rebate for a dosage form and strength of a single source drug or an innovator multiple source drug is increased,” the act says. (RAPS)
 
November 2, 2015

The program will help to ensure that manufacturers have good quality systems and may help mitigate regulatory risks by preparing manufacturers for Food and Drug Administration GMP inspection.

October 30, 2015

"Competition is essential in every part of our economy, and especially so in a market as complex and important as health care," Sen. Mike Lee, R-Utah, said about Walgreens’ planned acquisition of Rite Aid. 

October 28, 2015

The purpose of the group is to connect grassroots pharmacy advocates from across the country, and grow its ranks to be poised for action when critical issues arise in Congress, the White House or in the states.

October 28, 2015

Some 77% of those polled by the Kaiser Family Foundation in October said that ensuring the affordability of high-cost drugs for patients with chronic conditions should be the government’s top health care priority. 

October 27, 2015

Acting Deputy Director of the Dietary Supplement Programs at the Food and Drug Administration Cara Welch wrote in a signed affidavit on Sept. 28 that picamilon “does not fit any of the dietary ingredient categories” under the law.

October 21, 2015

“This crisis is taking lives — it’s destroying families and shattering communities all across the country,” President Obama said in remarks at a community forum meant to kick off his administration’s new push to curb opioid abuse. 

October 21, 2015

In light of a U.S. House of Representatives subcommittee on MTM programs, Rite Aid’s field clinical services director testified and both the NACDS and NCPA submitted statements calling for expanded MTM programs. 

October 16, 2015

Last month’s launch of the first generic biologic drug in the United States is the first step in a movement that some say could drive down the nation’s healthcare bill and bring new treatment options to thousands of patients across the country.

October 16, 2015

The New York Times is reporting that enrollment in health exchanges isn’t expected to grow much next year above current levels. “After an elaborate analysis of demographic data, Sylvia Mathews Burwell, the secretary of health and human services, said that 10 million people were expected to have marketplace coverage at the end of next year, up only about 100,000 from recent levels and millions short of earlier projections,” the report says. (The New York Times)

October 16, 2015

The University of Florida study found that an OTC decongestant on the market today is no more effective than placebo in easing nasal congestion caused by allergies in adults. 

October 15, 2015

The New Jersey legislation requires the Department of Health to post a link on its website containing a list of products in which dextromethorphan is an active ingredient. 

October 15, 2015

 Feds are probing the drug maker on drug pricing, distribution and patient assistance programs, according to the Wall Street Journal. “The company’s drug pricing has drawn scrutiny from doctors, hospitals and Democrats in Congress after The Wall Street Journal reported in April about how it and some other companies buy and then significantly raise the prices of drugs,” the report says. (Wall Street Journal, registration required)