Hot Topics: Pharmaceuticals

Blog Posts (34)

February 3, 2017

A Solution In Search of A Problem: Streamlining the FDA

by Craig Klugman, Ph.D.

A professional association for regulatory affairs posted an article on Wednesday reporting Trump’s comments “calling for a massive overhaul of US Food and Drug Administration (FDA) regulations.” Trump issued an executive that called for reducing the number of federal regulations (for each new one created, two must be retired).…

October 31, 2016 The Presidential Election Edition

by Craig Klugman, Ph.D.

Every four years the United States chooses a new chief executive. Although encoded in the Constitution, the idea that a person with such power would willingly surrender it and walk away to allow another to lead is remarkable.…

October 5, 2016

Right to Try is A Snake Oil Sale to “Dismantle the FDA”

by Craig Klugman, Ph.D.

Right to Try laws have been getting a lot of press lately with California being the 32nd state to pass such a statute.…

September 29, 2016

Stop Price Gouging Sick People

by Craig Klugman, Ph.D.

More and more frequently, stories are appearing of drug companies buying patents of investment firms buying drug companies and then raising the cost dramatically.…

September 21, 2016

FDA Approval Brought To You By Popular Demand

by Craig Klugman, Ph.D.

In a surprising move, the Food and Drug Administration approved Exondys, a drug that has not been proven to work, did not have a randomized control trial, and that recommended against  by an independent expert panel.  …

August 17, 2016

Weeding Out the Truth: DEA’s New Stance on Marijuana Largely the Same as the Old

by Craig Klugman, Ph.D.

According to the Department of Justice, marijuana offenses account for 12.5% of all people in federal prisons for drug offenses.…

April 11, 2016

Patient Satisfaction and the Possibility of Bad Medicine

In the March 18, 2016, AMA Wire Practice Perspective entitled “When Patient Satisfaction Is Bad Medicine” , Drs. Joan Papp (Case Western Reserve University) and Jason Jerry (Cleveland Clinic) make the argument that the institutional drive for higher patient satisfaction scores on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) questionnaires may be contributing to the opioid prescription drug crisis nationwide. They note the results of an Ohio State Medical Association-Cleveland Clinic Foundation survey 1,100 Ohio physicians:

… 98 percent of the physicians who participated reported that they felt increased pressure to treat pain, and 74 percent reported that they felt an increased pressure to prescribe opioids because of the perverse pain management incentives in the patient satisfaction surveys.


Additionally, 67 percent of respondents “agreed that, in general, physicians in the United States over-prescribe controlled substances to treat pain.”

            Drs. Papp and Jerry pointed to HCAHPS questions 2 and 3 specifically that may be a factor:

(1) “During this hospital stay, did you need medicine for pain?” Patients can answer “yes” or “no.” (2) “During this hospital stay, how often was your pain well controlled?” Patients can answer “never,” “sometimes,” “usually” or “always.” (3) “During this hospital stay, how often did hospital staff do everything they could to help you with your pain?” Patients can answer “never,” “sometimes,” “usually” or “always.”


Unless patients answer “always” to these last two questions, the hospital is considered an “underperformer” by Centers for Medicare & Medicaid Services (CMS) and may be financially penalized.

            With these survey results, one may reasonably wonder if a “cultural paradigm of overly aggressive pain management … exists and will continue to be a barrier to efforts to address the opioid epidemic.”

            Drs. Papp and Jerry offer three suggestions that might help: (1) Perhaps CMS should consider giving “partial credit” for responses for HCAHPS questions 2 and 3? It is very difficult clinically to “always” relive acute and chronic pain. (2) In the introductory question attention is directed toward “medicine”; there are many other pain modalities such as ice packs, improved positioning, physical therapy, and surgical intervention, that are not addressed. (3) Perhaps CMS should use “discomfort” rather than “pain” in the questions? As worded, there is little room for patients and doctors reflecting on other pain control options for rapid pain relief.

            The opioid prescription drug crisis in America is real. During the month of March 2016 alone, a great deal of attention has been directed to the problem. The U.S. Senate recently passed S.B. 524, the Comprehensive Addiction and Recovery Act (CARA) to provide “money for various treatment and prevention programs for a broad spectrum of addicts, including those in jail. It also strengthens prescription drug monitoring programs to help states and expands the availability of the drug naloxone, which helps reverse overdoses, to law enforcement agencies.”

The Massachusetts and Wisconsin legislatures enacted laws establishing new prescribing rules and allowing for the better disposal of controlled substances. And the Centers for Disease Control and Prevention (CDC) published their Guideline for Prescribing Opioids for Chronic Pain with advice for primary care clinicians not dealing with end-of-life or palliative care situations. Even so, much still needs to be done to improve pain control while minimizing risks of addiction and abuse. All the more reason to align as many forces as possible – including a revision of the CMS HCAHPS patient satisfaction questionnaires – to maximize best practices in prescribing opioids.


The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

March 1, 2016

Senator Markey and the Unfortunate Politicization of the F.D.A.

Senator Edward (Ed) John Markey (D.-Mass.) announced on January 24, 2016, that he was exercising one of his prerogatives as a United States Senator and placing a hold on the confirmation vote for Food and Drug Commissioner nominee Robert Califf, MD.  President Obama nominated Dr. Califf on September 15, 2015, to succeed Margaret Hamburg, MD, who left the position last year Interestingly, Dr. Califf won unanimous approval by the Senate Committee on Health, Education, Labor, and Pensions. However, Senator Markey questions Dr. Califf’s fitness to serve not because he lacks credible individual qualifications, but because he is upset with the way the agency deals with prescription opioid medicine approvals, and specifically the manner in which the F.D.A. handled adding a label indication for the narcotic pain killer OxyContin (Purdue Pharma LP) to treat children’s pain.

Moreover, Markey is not alone. At least two other senators agree that Califf is not a good choice for F.D.A. commissioner and also place “holds” on the nomination: Senator Bernie Sanders (Ind.-Vt.) believes that Califf is too close to the pharmaceutical industry and lacks commitment in controlling drug prices; and Senator Lisa Murkowski (R.-Alaska) objects because the F.D.A. approved a genetically modified salmon which is a competitor in the marketplace to “natural” Alaska salmon.  Because of these member “holds,” Dr. Califf’s nomination may never come to the Senate floor for a confirmation vote. And with the Obama Administration in its last year, it may not really matter that much anyway. Dr. Califf is presently serving as Deputy Commissioner for Medical Products and Tobacco; and the F.D.A.'s chief scientist, Stephen Ostroff, MD, is serving as acting head of the agency.  Both Drs. Ostroff and Califf are relatively recent F.D.A. administrative additions and probably will collaborate in effecting Obama policy directives.

Regardless, the question remains: Should senators hold up F.D.A. appointments for what appear to be personal political views? Views that are clearly are important, but grounded more in policy disagreements with agency actions that may not be related to the qualifications of the candidates nominated to manage the agency? Surely there are more civil and direct ways of expressing opinions without attempting to grind government to a halt?


The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.


February 5, 2016

The FDA Should Have No Role in Setting Prices for Off-Patent Pharmaceuticals

An article that appeared in the Journal of the American Medical Association on January 4, 2016, written by Johns Hopkins Institute of the History of Medicine and Bloomberg School of Public Health professors Jeremy A. Green, Gerard Anderson, and Joshua M. Sharfstein recommended that the Food and Drug Administration (FDA) act to improve access to approved generic drugs that are becoming scarce because of a lack of competition. It’s surprising that respected historians and health policy educators believe that the FDA should have any such governmental role. As highly regarded as they are, the authors appear neither to fully understand FDA and drug regulation history or health care delivery competition oversight. The FDA has never had statutory authority to regulate drug prices, period. And, they rightly shouldn’t have.

The FDA exists to protect the public safety, health, and welfare by assuring that drugs marketed in the US are safe and effective. The reasonableness of the prices for these drug products is of no concern to the FDA as a regulatory body. In the general scheme of federal oversight, fair business and trade practices are the responsibility of the Federal Trade Commission (FTC) and the Civil and Criminal Divisions of the Department of Justice. These governmental authorities are responsible for the enforcement of the anti-competition and antitrust laws. The FDA has enough to do already; drug pricing should be left in the regulatory hands that are charged with this duty without involving the FDA. There’s no real value of involving the FDA here, except perhaps to muddle the waters more.

Green, Anderson, and Sharfstein are appropriately outraged by the unbelievably high prices charged for some off-patent drugs.  But for the most part, the decreased availability is a function of market forces. As drugs age – and loose their patent protections – newer drug entities are approved and take their place in medicine’s armamentarium. The example the authors cite of the wide availability of amoxicillin is good example of an off-patent drug that still available because the market has yet to find a safer, more effective, low cost alternative for the millions of patients in the US that need a first line broad spectrum antibiotic. Few off-patent drugs have have the same broad use and hence the same wide availability. There are some but their use and availability is a function of the market, not FDA oversight. The shortages or limited supplies of most drugs result not from reduced competition but from the fact that fewer patients need them.

In those situations, in which unscrupulous marketeers and venture capitalists step in the raise the prices of drugs in short supply – even when there are many patients need and can benefit from them – the circumstances are more similar to price-gougers taking advantage of an unfortunate situation. Some states define this as criminal behavior and the alleged misconduct is prosecuted and guilty parties are punished. This would be true if the product were drugs, or milk or gasoline, whether shortly after a natural disaster or some other similar calamity.

Moreover, the recommendations Green, Anderson, and Sharfstein make regarding the FDA’s role are poorly thought out and inconsistent with current commonly accepted practices: (1) The authors think the FDA should allow more “drug compounding” by pharmacists to meet any shortages. Any “compounding” of the volumes necessary to meet shortages would clearly be “manufacturing” as defined in the Food, Drug and Cosmetic Act (FDCA). “Compounding” is typically undertaken by an individual pharmacist for an individual patient; larger scale production is “manufacturing” and FDA oversight would be mandatory. For many years, the FDA has sought greater oversight of “compounding” over the objection of state pharmacy regulators. They have achieved that goal of sorts with the enactment of the Drug Compounding Quality Act (which was Title I of the Drug Quality and Security Act of 2013). (2) The authors also suggest that the FDA “temporarily permit the importation of drug products reviewed by competent regulatory authorities and approved for sale outside the United States.” It’s generally understood that India already manufactures about 80% of the world’s generic drug supply. Most drugs available in the US are already manufactured in India and China. Drug manufacturers moved to these countries over time for economic reasons, because it’s just too expensive to manufacture drugs in the continental US anymore. Of course the approval process for those products that will be marketed here is still handled by the FDA, but the actual product manufacture is elsewhere. It’s particularly curious that Dr. Sharfstein – as a former Principal Deputy Commissioner within FDA from 2009 to 2011 – should advocate for such FDA roles when it was the FDA that was actively involved in drafting the Drug Supply Chain Security Act (which was Title II of the Drug Quality and Security Act of 2013) to better assure the quality of drugs available in the US regardless of point of manufacture. 

Even more curious, the authors recommend the FDA speed up it’s generic drug regulatory approval process. Again, as Principal Deputy Commissioner for the FDA, it seems that Dr. Sharfstein and other FDA officials could have done that already if there had been political will to do so.

Regardless, the FDA should be left alone to assure the safety and efficacy of drugs, and not be involved with drug pricing.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.


December 23, 2015

A Suggestion To Make Prescription Medicine Behind-the-Counter

by Craig Klugman, Ph.D.

I recently returned from a vacation to Central America. Besides having some adventures, I also noticed that the local towns had a large number of pharmacies—far more than would be expected of towns with small populations.…

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Published Articles (1)

American Journal of Bioethics: Volume 14 Issue 3 - Mar 2014

The Ethics of Advertising for Health Care Services Yael Schenker, Robert M. Arnold & Alex John London

News (103)

March 21, 2017 9:00 am

Federal advisory panels agree Opana's risks outweigh benefits (USA Today)

The new extended-release version of Endo Pharmaceuticals’ Opana may even be more dangerous than the version it replaced, according to critics including the advocacy group Public Citizen. Two Food and Drug Administration advisory panels seemed to agree, voting 18 to 8 that it presents more risks than benefits to society. Next it’s up to the FDA to decide whether to act on the panels’ advice, which it generally does. Possible actions include changes to labels, restriction of prescriptions and an outright ban.

March 15, 2017 9:00 am

OxyContin Maker Purdue Pharma Hit With Unprecedented Lawsuit by Washington City (NBC News)

In January, the city filed a first-of-its-kind lawsuit against Purdue Pharma alleging the drug maker “supplied OxyContin to obviously suspicious physicians and pharmacies,” ultimately failing “to prevent the illegal diversion of OxyContin into the black market.”

While other suits against the company by states and municipalities have accused Purdue Pharma of deceptive marketing — allegedly playing up OxyContin’s effectiveness while playing down its addictiveness — Everett’s lawsuit is the first to claim the company knew its drugs were being diverted and did nothing to stop it.

March 10, 2017 9:00 am

Drugs are killing so many people in West Virginia that the state can’t keep up with the funerals (Washington Post)

Deaths in West Virginia have overwhelmed a state program providing burial assistance for needy families for at least the fifth year in a row, causing the program to be nearly out of money four months before the end of the fiscal year, according to the state’s Department of Health and Human Resources (DHHR). Funeral directors in West Virginia say the state’s drug overdose epidemic, the worst in the nation, is partly to blame.

March 1, 2017 9:00 am

Ebola funding surge hides falling investment in other neglected diseases (Nature)

Global funding for research on neglected diseases — which include tuberculosis, HIV/AIDS and malaria — is at its lowest level since 2007, according to the annual G-FINDER investment report by Policy Cures Research, a health-policy analysis firm in Sydney, Australia.

February 17, 2017 9:00 am

An old drug gets a new price to fight a rare disease: $89,000 a year (Washington Post)

An old steroid treatment, long available outside the United States, received approval this week for a rare disease that afflicts about 15,000 Americans. Though not previously approved in the United States, the drug, deflazacort, has for years been available to patients suffering from the devastating and fatal disease Duchenne muscular dystrophy; families can import it from abroad for about $1,200 per year on average. The new list price for the drug? $89,000 a year.

January 31, 2017 9:00 am

Vaccine initiative marks bold resolution (Science)

Clearly, private companies cannot be expected to invest on their own. But it is incumbent on governments to invest, and thus address this market failure, in partnership with pharma. It is therefore encouraging that there is now a solid plan to do just that: the Coalition for Epidemic Preparedness Innovations (CEPI), launched on 18 January at the World Economic Forum in Davos, Switzerland, aims to develop and take through early clinical trials vaccines against potential threats. It already has enough cash to work on three — MERS, Nipah-virus infection and Lassa fever.

December 20, 2016 9:00 am

OxyContin goes global — “We’re only just getting started” (LA Times)

Former U.S. Food and Drug Administration commissioner David A. Kessler has called the failure to recognize the dangers of painkillers one of the biggest mistakes in modern medicine.

November 3, 2016 8:00 am

More Children Are Being Poisoned By Prescription Opioids (NPR)

Young children and teenagers are increasingly likely to be poisoned by opioid painkillers that are often prescribed for other family members, a study finds.

October 28, 2016 8:00 am

Big pharma is gearing up to defend drug prices (Washington Post)

The skyrocketing costs of prescription drugs has been noticeably absent from discussion in the presidential debates — even as bipartisan anger about price gouging has united Congress. But the trade group for the pharmaceutical industry, PhRMA, is gearing up to defend drug prices after the election, seeking an additional $100 million in annual dues from its members, according to a report from Politico.

October 27, 2016 8:00 am

How drugs intended for patients ended up in the hands of illegal users: ‘No one was doing their job’ (Washington Post)

For 10 years, the government waged a behind-the-scenes war against pharmaceutical companies that hardly anyone knows: wholesale distributors of prescription narcotics that ship drugs from manufacturers to consumers.

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