Recent Recap for Week Ending 11/10


  • FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirments

A recent announcement by FDA commissioner Scott Gottlieb confirmed that a new guidance will soon be released regarding the loophole that allows companies to designate approved adult drugs as orphaned drugs for use in pediatric populations. In the past, the current guidelines allowed companies to use a drug in this way for an originally unintended pediatric population without any trials on the population itself. Once released, this guidance will close this loophole and companies will be required to run the proper trials before using drugs in pediatric populations, resulting in more pediatric research.

Challenging drug-development environments have led drugmakers to collaborate with other life-sciences companies. The primary challenges drugmakers face are complex specialty drugs, a growing emphasis on the use of data such as patient-reported outcomes and real-world evidence, and the turn to value-based reimbursement.

The family name behind institutes as Washington’s Sackler Gallery, Harvard’s Sackler museum, and the Sackler at the Louvre is also behind Purdue Pharmaceuticals. Purdue Pharma is renowned for its development of the prescription painkiller, OxyContin. It’s development was extremely successful, generating one billion dollars within the first 5 years of its introduction. But OxyContin poses serious risks. Patients prescribed OxyContin too frequently become addicted and require higher doses to achieve the same analgesic effect. Doctors are puzzled but are still allowed to write scripts for OxyContin. Controversy caused the DEA and FDA to get involved regarding OxyContin’s overstated safety profile.The Sackler family adamantly denies any purposeful misrepresentation of OxyContin’s addictive potential and places the recent upsurge in OxyContin overdoses on the poor judgement of the patient.

A public citizen suit has been brought against the FDA related to benzocaine in infant teething products. The suit is asking the FDA to update labeling to include contraindications for infant teething in products containing benzocaine. More than three years have passed since the suit was originally filed.

  • Why Takeda thinks partnerships can revive innovation in pharma

Takeda is reaching out and creating partnerships with various players in the pharma field, from small biotechs to large R&D companies. This flurry of partnership activity is aimed at bringing in the best new innovative science with the hopes of a successful pipeline of discovery.

A former Acclarent sales rep was fired, allegedly after raising concerns about off label marketing of a spacer device. A judge has ruled that she has grounds to sue Acclarent, but not its parent companies Ethicon or J&J.

Medical Devices

Puerto Rico is still recovering from Hurricane Maria, and its medical device manufacturing sites are no exception. Most sites reports some wind or water damage, and they are trying to get in touch with employees who have lost electricity and access to telecommunication.

The Maternal and Child Health Bureau offers two prizes for health IT developers that develop digital platforms for women and children in low income families. The first digital platform will seek to identify affordable, remote prenatal monitoring solutions for women in medically underserved communities. Second, IT developers are challenged to address rising childhood obesity rates in underserved communities. IT developers that meet these challenges will receive a large monetary compensation.

The Center for Devices and Radiological Health is now advocating for patient contributions to the regulatory medical device decision making process. The Center recently developed a home dialysis system which arguably allows patients to perform hemodialysis in the comfort of their own home. In this pursuit, the Center collaborated with the medical device developer, NxStage, to quantify a patent’s level of risk when choosing at home care in lieu of treatment at a dialysis center. The FDA is now on board and is working to develop mitigation strategies with NxStage for patients choosing to do hemodialysis at home.


Big pharma companies are using social media to target specific audiences and regions with their digital marketing strategies over the next 1-2 years. Facebook is the most widely used social media platform for many of the companies, with Youtube, LinkedIn and Twitter following close behind in popularity. Other social media forums are also used to various degrees to help companies with their marketing strategies.

Like many other places in the country, Colorado has seen an increase in prescription and illicit opioid abuse. However, the addiction rate in Colorado is even higher than many other states. A study from Boston Medical Center has found that Colorado doctors were receiving $4.6 million for opioid manufacturers during the height of the crisis, which may have contributed to rising addiction rates.

  • FDA To Change How Prescription Drugs And Biologics Are Advertised

The FDA is asking the public to contribute to its public docket regarding the marketing of biologics and prescription drugs. They are asking that interested parties submit comments by November 20, 2017 either in a letter or via an electronic forum.

In this letter, the agency is urging VA based Cipher Pharmaceuticals to comply with the FDCA in the marketing of its opioid painkiller, Conzip. The drug is approved only for patients who have been non-responsive to other forms of pain relief. The FDA says that the company has failed to disclose harmful side effects of its opioid painkiller, which could mislead patients into believing that it can be used on an “as-needed” basis.

Pricing, Reimbursement and Medical Affairs

Pablo Graiver, founder of travel search engine Kayak, has had a lifelong interest in healthcare. He has recently launched Antidote, a search engine that connects people with relevant clinical trials. He hopes the internet based tool will improve enrollment in clinical trials.

Anthem launches new PBM after fallout with Express Scripts (H/T to Andrea M. Sokolich)

National health insurance provider Anthem will end its contract with Express Scripts, the result of a yearlong feud involving accusations of overcharging the insurer and a $15 billion lawsuit. The insurer will partner with CVS health to launch IngenioRx, which will take over PBM services for the company. CEO Joseph R. Swedish says that the solution will “strenghten the value offered to the marketplace,”.

Dr. Rick Boulay, a gynecologic-oncologist, expresses his frustration when trying to convince medical specialists that the cancer treatments that are often denied by insurance companies are the same ones that can save a person’s life. Dr. Boulay has seen too often a patient’s health rapidly declined due to problematic exchanges with insurance companies, called peer-to-peer counseling, sometimes resulting in a patient’s need to withdraw from treatment or even a patient’s death due to denied treatment. Dr Boulay doubts that insurance doctors practice according to that first do no harm.

Clinical Trials

Physicians whose main role is not clinical research are sometimes challenged to adhere to study protocols, especially when they see a better option for their patient. Practices participating in clinical trials must be careful to consider the requirements of the protocol, and how their standard course of treatment deviates from the protocol.

Several years ago, Novartis released Cosentyx, a fully-human biologic indicated for rheumatism and psoriatic conditions. It has shown to be especially effective in treating Ankylosing Spondylitis, a debilitating form of rheumatism that impedes mobility and can affect people as young as 20 years old. The drug has stopped disease progression for up to four years.


  • AstraZeneca Asthma Candidate Tralokinumab Fails Two Phase III Trials

AstraZeneca has released results of two failing Phase III clinical trials for an asthma drug. The lead investigator calls the results “disappointing”, especially for patients with severe asthma that is not well controlled.


Puerto Rico is a major manufacturing site for pharmaceutical companies, including Pfizer and Eli Lilly. The island exports seven of the world’s ten most sold medications. Following Hurricane Maria, pharma companies say that drug supplies will not be affected.

OH Gov Kasich has recently signed a new law changing the licensing requirements for health care providers (HCPs) distributing drugs in OH. This applies to drugs which are considered part of Ohio’s list of Dangerous Drugs. This is part of the state’s efforts to control the opioid epidemic.

The pharmaceutical industry has long embraced the batch supply method of manufacturing. Now, the FDA wants to push the industry toward continuous manufacturing in an effort to ensure drugs are available. They say it will mitigate failures and improve manufacturing. The FDA is asking for industry input as it develops guidelines for manufacturers.


Nearly 400 hospitals based in the United States implement electronic health records, computerized prescription-order-entry systems, and barcode assisted medication administration systems. In 2016, 99% of hospitals used electronic health records and a comparable fraction used computerized medication administration systems. Technology has the potential to improve a doctor’s access to clinical information and decrease a pharmacist’s chance of medication errors. A survey found that pharmacists are increasingly involved in medication management. Approximately 75% of pharmacists now access medical history at the time of hospital admission.

Magellan Health took several hits on a recent FDA audit, related to conditions in its one of its drugmaker’s cleanrooms. The New York City facility was cited for design violations including the proximity of the sink to the isolation area, as well as microbial contamination. Staff were caught in inappropriate cleanroom attire, including wearing jewelry outside of the gown.

Pharmacists are trained to provide information about a medication’s side effect profile and drug-drug interactions to patients before, during, and after dispensing a medication. Clinical expertise is needed at specialty pharmacies but to a higher standard of care. Documentation, or the exchange of information from the pharmacist to the patient, is critical for a specialty pharmacist to provide the highest standard of care. Pharmacists need to ensure that they are asking the right questions when a speciality medication, in particular, is dispensed.

Medical Marijuana

Hurricane Irma was the largest storm to hit FL since medical marijuana was legalized there last November. While power outages and flooding were common, most plants weathered the storm without damage. Growers have reported only minor damages to facilities that will not affect the supply of the drug to FL patients.

The Michigan Bureau of Medical Marijuana Regulation has been working with the state Attorney General’s Office to implement regulations around the use of medical marijuana. Although about 250 marijuana dispensaries are currently operating in the state; the Michigan Supreme Court previously ruled marijuana dispensaries illegal.The dispensaries may be forced to close until new regulations are enacted.

A Pennsylvania-based medical marijuana company is seeking legal action against the state following a denied permit to distribute marijuana. It is claiming that the application process was unclear and unfair, they are asking that PA stop issuing all permitting until it clarifies its laws. PA lawmaker Daylin Leach is requesting that the company drop the part of its suit which effectively blocks PA from pursuing its medical marijuana program.

Privacy and Cybersecurity

In a particularly disturbing form of cybercrime, patients using Smiths Medical’s infusion pumps are left vulnerable to malware that causes the device to malfunction. The pumps can be used to administer pain-management drugs, insulin, or hormones to patients. The FDA has alerted companies that it will consider cybersecurity in its approval of medical devices.

Our expectation of privacy has changed drastically in the last generation, and we continue to move in the direction of transparency as a culture.  Some wonder how we will maintain our right to privacy in an era where companies and governments have access to our online activities and other personal information.

Cybercrime is a fast-growing threat to economic security in every country, and pharma businesses are likely targets for both their monetary wealth and vast library of proprietary information. Pharma companies need not be victims of cybercrime, however. There are steps to be taken to lessen the risk of cyberattack- saving valuable time and money by prevention.


The New York Times has a Virtual Reality team which seeks to identify interesting applications of VR. In this piece, team member Maureen Towey explains how they partnered with two deaf people with hearing assistance devices to experience how music feels. They used animations to convey the tactile and visual experience of music for the deaf.

When we think of robots, we probably don’t consider ones as small as researches at the University of Manchester have developed. One billion times smaller than a grain of salt, these tiny robots can build molecules from atoms. They may have a big impact on manufacturing and medicine in the next few years.

Researchers in the mechanical engineering department at Columbia University have developed an artificial actuator three times stronger than natural muscle. The artificial muscles are 3D printed, and can mimic natural muscle movements.


  • FDA to Hold Public Meeting to Discuss the Development of a List of Pre-DSHEA Dietary Ingredients

The FDA invited all interested parties to attend a meeting on October 3 to address a potential need to add dietary ingredients used before 1994 ingredients to the DSHEA list. They specifically asked attendees to weigh in on the process that pre-dated the 1994 law. Interested parties were able to attend either in person (College Park, MD) or via webinar.

Although no adverse reactions were reported, the NY RI Wang Food Group has been ordered by the USDA to recall over 50,000 lbs of sausage distributed in NY and NJ. The sausage tested positive for milk protein, a common allergen, but was not properly labelled or cautioned to indicate that it contained dairy products.

Some food manufacturers voluntarily place a calorie count on the front of their packaging in addition to the required nutritional label. In the case of Wrigley Company’s Starburst Gummies, the calories listed on the front of the packaging were less than the number of calories reported on the nutritional label. A class action lawsuit in Illinois looks to hold the company responsible for what plaintiffs say is false advertising.


An Instagram post could always be a paid advertisement. The main selling point to consumers is the idea that the influencer actually uses the product. Brand name companies partner with social media campaigns such as Instagram that allow them to reach younger consumers. This is especially helpful for brands with smaller budgets and limited marketing success. But nearly all brands fail to feature influencer control on their accounts. If they were to do so they would be afforded more opportunity to capitalize on their partner’s consumer engagement.

Proctor & Gamble, the makers of Pampers Sensitive Baby Wipes, have issued a voluntary recall for a “Mega Box” of their wipes. They said that a small amount of the wipes produced on August 25 2017 may have been contaminated by debris from the warehouse floor.

  • Own a cosmetics business? DYK that P.O. Box addresses don’t meet cosmetic labeling requirements?

The FDA has compiled a list of 15 FAQs that those new to the cosmetics industry need to know. There are surprising regulations, such the requirement that a company lists a physical address- not a P.O. Box.

Patient Advocacy

Patient advocates have expanded their role beyond their typical responsibility to spread awareness about health conditions. Some advocates are educated on the science behind the disease. In the case of the breast cancer drug Bevacizumab, patients testified before the FDA about the harsh side effects and inefficacy of the drug.

The DEA’s efforts to enforce the law at opioid distribution facilities are being curtailed by a new bill. An investigation by the Washington Post and 60 Minutes found that the original draft of the bill was written by a pharma lobbyist. Sen. Orrin Hatch of Utah says to “leave the conspiracy theories to Netflix”, but some are concerned that the pharma lobby is too closely involved in this legislation.

Huntington’s disease is a devastating degenerative neurological condition with no cure and limited treatment options. Patient advocacy groups for Huntington’s in Europe and North America recently launched a joint effort to help bring patients’ voices to the forefront of research. The newly formed group, HD-COPE, hopes to inform researchers and physicians about what Huntington’s patients want from research.