2017-08-07 23:17
It's all about the money Read More
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Drugwonks.com is the web log of the Center for Medicine in the Public Interest (CMPI), a forum offering rigorous and compelling research on the most critical issues affecting current drug policy.
2017-08-03 17:23
2017-08-03 15:39
When it comes to the US opioid epidemic, one overlooked culprit comes straight from our healthcare system: pharmacy benefit managers (PBMs). To improve their bottom line, they're blocking ac… Read More
2017-07-25 14:42
The Reagan-Udall Foundation has released an online tool to help patients and doctors find drugs that quality for the FDA program called expanded access, or compassionate use Read More
2017-07-19 12:36
Former Sidley Austin partner and product liability specialist Rebecca Wood has been named FDA chief legal counsel. Wood represented multiple life science clients during her nearly 17 years a… Read More
2017-07-14 14:40
Instead of making PBMs transparent we need to make them disappear Read More
2017-07-14 10:26
Although 10 new opioid products with abuse-deterrent formulations (ADF) have received regulatory approval in the United States, lack of willingness by insurers to reimburse patients for thei… Read More
2017-07-12 21:02
2017-06-26 18:01
What a great combination – Steve Usdin interviews Scott Gottlieb Read More
2017-06-20 12:20
Thousands of Americans could die waiting for the FDA to approve new, lifesaving treatments if Congress fails to reauthorize a 25-year old law this summer Read More
2017-06-19 12:06
Maine lawmakers are advancing LD 1280, a bill that seeks to reduce patients' health care bills by speeding up the introduction of low-cost generic drugs. The bill has a noble goal. But it is… Read More
2017-06-16 17:06
n a blog post Thursday, FDA Commissioner Scott Gottlieb outlined regulatory steps designed to promote development of digital health technologies Read More
2017-06-14 15:34
2017-06-14 12:19
If you’re interested in the FDA’s Patient-Focused Drug Development program and attending next week’s BIO bash, hope you can attend (and participate) at this interactive pan… Read More
2017-06-12 20:08
2017-06-12 11:46
In March, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSARM). voted 18-8 that Opana ER&rsqu&hell…Read More
2017-06-08 23:11
Apparently, people with rare diseases should do without to appease the anti-pharma crowd Read More
2017-06-08 15:35
The Joint Economic Committee (JEC) will hold a hearing on June 8th to explore the economic aspects of the opioid crisis. We'll see Read More
2017-06-04 16:30
Per, "The Single-Payer Party? Democrats Shift Left on Health Care," (NYT, June 3, 2017) it seems somewhat ham-handed to have only one paragraph, deep inside the page 16 jump of a Page One ar… Read More
2017-05-30 13:11
One place to look for smart policy solutions is just north of the border, where medical experts and public health officials in Canada are also concerned about the abuse of prescription opioi… Read More
2017-05-25 10:20
President Trump’s FY18 FDA budget request envisions cutting medical product safety funding by $17.8 million. The cuts would reduce the agency’s ability to ensure the safety of im… Read More
2017-05-20 16:04
In a recent Washington Post op-ed, Bill Schultz, the former deputy commissioner for policy of the Food and Drug Administration during the Clinton administration, incredulously offers that FD… Read More
2017-05-09 22:02
It’s disappointing to say the least when our fine elected representatives place scoring transient political points in front of advancing the public health.
Such is always the case with… Read More
2017-05-09 18:54
Nearly one third of drugs newly approved by the US Food and Drug Administration (FDA) are affected by safety issues that were not known at the time of approval, a study has shown Read More
2017-05-09 17:26
2017-05-06 19:31
In the wake of the unraveling scandal surrounding the agency’s television viewing habits, CDRH spokesperson Teng Kay has denied allegations they have been instructed by “unconfir… Read More
2017-05-05 19:58
2017-05-05 12:06
The QuintilesIMS Institute has issued a very interesting new report, “Medicines Use and Spending in the US: A Review of 2016 and Outlook to 2021.” It’s a must-read for many… Read More
2017-05-04 22:03
Representative Morgan Griffith (R/VA) has introduced HR 1703, the Medical Product Communications Act. It’s legislation that would take a lot of the ambiguity out of the FDA’s big… Read More
2017-05-03 12:58
When it comes to 21st century pharmacovigilance, sometimes it’s important to look … backwards. According to the 10th century Arab physician, Ibn Sina, “The time of action… Read More
2017-04-27 15:18
2017-04-21 17:25
President Trump wants to lower drug prices and reinvigorate domestic pharmaceutical manufacturing. Bravo. But standing in the way is the inside-the-Beltway gospel that preaches that regulat… Read More
2017-04-17 13:19
House Judiciary Committee Chairman, Rep. Bob Goodlatte (R/VA.) wants drug side-effect ads that are run by lawyers to include a warning that patients should talk with their doctors before adj… Read More
2017-04-14 21:54
WASHINGTON, DC – The leaders of the Senate and House health committees today released a discussion draft of bipartisan legislation reauthorizing the Food and Drug Administration user f… Read More
2017-04-12 11:47
It's time to go beyond FDAMA 114. It's time for PIE Read More
2017-04-06 13:18
It's not about speed, it's about predictability Read More
2017-04-06 10:57
European, national, and regional authorities should invest in awareness-raising campaigns to increase public knowledge about medicinal safety and adverse drug reaction (ADR) reporting Read More
2017-04-06 02:05
“I think Scott is very much for good regulation, and very much against bad regulation,” Pitts said. “Importantly, he recognizes where FDA core mission stops, and where miss… Read More
2017-03-30 14:11
In what some observers are calling a misguided effort, Arizona has become the first state in the nation to pass a law allowing drug makers to promote their medicines for so-called off-label… Read More
2017-03-29 16:29
2017-03-29 15:02
2017-03-28 14:25
Nothing is more illustrative of the price/value discussion than PCSK9s. Just what are they worth? What's innovation worth? Read More
2017-03-27 13:57
When pundits, politicians, and policymakers speak about “sales and marketing,” the picture they are painting is of direct-to-consumer pharmaceutical advertising – the publi… Read More
2017-03-17 11:35
Four former FDA commissioners warn that proposals to allow importation of pharmaceuticals would create serious risks for consumer and patients, and would produce only minimal savings Read More
2017-03-16 14:31
2017-03-15 12:47
The ranking member of the Senate Finance Committee will roll out a proposal today to lower drug costs by targeting prescription benefit managers (PBMS) — middlemen who negotiate discou… Read More
2017-03-14 15:26
2017-03-14 12:41
At the recent abuse deterrent opioids summit, CDER Deputy Director for Regulatory Programs Dr. Doug Throckmorton presented the FDA’s position. He said, “We must move on from olde… Read More
2017-03-13 14:18
Former deputy commissioner will also likely push increased use of biomarkers and more flexibility in off-label communication, among other reforms. President Donald Trump's choice of Scott Go… Read More
2017-03-09 12:53
Governor Cuomo’s budget aims to control drug pricing through price controls . While this is a good political sound bite, it’s bad public policy with dangerous unintended conseque… Read More
2017-03-06 13:43
Finally, some bipartisan sanity on healthcare transparency. Representatives Doug Collins (R-GA), Buddy Carter (R-GA), Dan Loebsack (D-IA), John Sarbanes (D-MD) and John Duncan (R-TN) have in… Read More
2017-03-02 00:33
Drug importation is a vampire issue — you can drive a stake through its heart, but it won’t die.” Read More
2017-03-02 00:28
2017-03-01 06:41
What's the best way to improve health care for billions of people in the developing world? If you answered, “Attack health care firms,” you qualify for a job with the United Nati… Read More
2017-02-28 22:24
2017-02-28 18:00
2017-02-27 12:18
An interesting post at OhMD discusses a new study showing that “96% of patients report leaving their doctor’s office with limited knowledge of how to use the patient portal. Of t… Read More
2017-02-24 19:45
2017-02-22 18:55
2017-02-21 12:40
The gathering and appraisal of real world evidence can expedite identification of problems before they become deadly. If we can identify misuse earlier, we can help eradicate abuse and addic… Read More
2017-02-17 02:03
2017-02-16 13:14
President Trump will ask prominent vaccine safety skeptic Robert F. Kennedy Jr. to lead a planned commission to study vaccine safety, Kennedy said Wednesday. Commission members will include… Read More
2017-02-16 12:54
2017-02-15 12:46
No wonder PBMs are running scared. When their profits and practices are made transparent they should be afraid – very afraid Read More
2017-02-14 13:09
2017-02-09 19:54
PBMs asks Trump to let them hurt more patients Read More
2017-02-08 17:25
2017-02-02 13:44
President Trump recently pledged to let federal officials negotiate the prices of drugs covered under Medicare. He claims this will save taxpayers billions of dollars. Nobody doubts that Tru… Read More
2017-02-01 23:06
2017-01-26 14:57
Governor Terry McAuliffe today announced that the Prescription Monitoring Program has been awarded a grant to help integrate use of its data in doctors’ and pharmacists’ regular… Read More
2017-01-23 16:50
“I wonder if this memo was written on an electric typewriter -- since it seems to represent thinking from the 1980s,” Pitts wrote to Inside Health Policy Read More
2017-01-23 16:42
Pitts called the original bad ad program "a complete waste of time," maintaining that FDA never really determined what was a bad ad, and that FDA should instead be focusing on regulating saf… Read More
2017-01-23 14:53
“This memo is a regulatory temper tantrum,” said Peter Pitts, a former FDA associate commissioner who heads the Center for Medicine in the Public Interest, a think tank that is f… Read More
2017-01-20 13:11
Closer to libel than truth Read More
2017-01-19 05:56
FDA has released two new documents that address off-label communications about medical products. A draft guidance outlined questions and answers regarding communication with payers about hea… Read More
2017-01-18 04:45
The FDA’s new draft guidance on interchangeability of biosimilars will require most biosimilars' sponsors to conduct studies showing that switching between a biosimilar and its referen… Read More
2017-01-17 16:33
2017-01-13 13:09
In final guidance released Thursday on naming of biologic drugs, FDA reiterated that each biologic should receive a non-proprietary "core name" plus a unique four-letter suffix that is devoi… Read More
2017-01-12 18:55
2017-01-09 15:57
Insurers hurt patients by switching drugs to save money Read More
2017-01-05 13:10
The truth does not cease to be the truth because it isn't politically expedient Read More
2016-12-20 12:32
Allowing the federal government to negotiate drug prices, as suggested by Minnesota Sen. Amy Klobuchar’s column “Let’s work with Trump to reduce drug prices,” would r… Read More
2016-12-16 16:43
Taming cancer drug prices will come at a heavy human cost Read More
2016-12-15 13:21
"It is important for the commissioner to be a change agent, not a bomb thrower," Read More
2016-12-14 22:35
2016-12-14 14:08
As Abraham Lincoln said, “Patents add the fuel of interest to the passion of genius.” Read More
2016-12-09 03:10
A great deal of work will be required to pave the road for the use of real world evidence in regulatory decisions, wrote FDA Commissioner Robert Califf and 14 other FDA staff members in a co… Read More
2016-12-09 03:05
2016-12-08 03:09
Who might be the next FDA Commissioner? Read More
2016-12-07 16:25
Competition is about innovating to increase profits, not about lowering prices Read More
2016-12-07 07:03
The 21st Century Cures Act provides a legal foundation for regulatory innovations including approving supplemental indications based on real-world evidence and approving antimicrobial drugs… Read More
2016-11-21 04:48
2016-11-15 13:28
Lawmakers are pushing forward with the Creating and Restoring Equal Access to Equivalent Samples (Creates) Act. The bill’s sponsors hope a series of new legal provisions will make it e… Read More
2016-11-08 20:35
Kareem Abdul-Jabbar’s toughest fight wasn’t on a basketball court. In his early 60s, the six-time NBA champion was diagnosed with leukemia, the deadly blood cancer. Fortunately… Read More
2016-11-04 12:14
According to the latest report from the Altarum Institute, “moderate 2016 health spending growth continues a slow downward trend.” Unfortunately this doesn’t fit the narrat… Read More
2016-11-02 16:54
Insurerspeak translated Read More
2016-11-02 11:37
FDA, Industry Focus on Abuse-Deterrent Opioids No consensus immediately apparent after 2-day meeting FDA officials and representatives from both the generic and branded drug industries spent… Read More
2016-11-01 15:24
The November issue of Lancet Oncology focuses on pharmacovigilance and drug safety. The lead editorial drives home some key points: At a time when the number of biological agents due to come… Read More
2016-10-26 18:39
2016-10-24 00:34
In a recent tweet, Senator Bernie Sanders made it clear he’s upset about high drug prices. Less clear is that his righteous wrath will put patients in harm’s way. He proved yet… Read More
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