Regulatory Focus™ > News Articles > RegBits: 4 Things to Know About Healthcare Product Regulation Today (17 September 2014)

RegBits: 4 Things to Know About Healthcare Product Regulation Today (17 September 2014)

Posted 17 September 2014 | By Alexander Gaffney, RAC

RegBits: 4 Things to Know About Healthcare Product Regulation Today (17 September 2014)

Welcome to RegBits, a new way to get an at-a-glance look at important regulatory news stories. Today's top stories include the European Parliament taking a hard look at drug pricing, recommendations to improve FDA's 510(k) process, a new chocolate-flavored cough syrup which might cause problems, and two new device reclassifications.

EU Takes Aim at High Drug Prices

The US isn't the only region where high drug prices—and in particular the price of the new hepatitis C drug Sovaldi—is leading to a wider debate about drug pricing and industry profits.

In an announcement on 16 September 2014, members of the European Parliament said they will hold two hearings over the next two months focused on the drug pricing issue, citing the "increasing burden on healthcare systems" and the potential for high prices to threaten "equal access to treatments."

While individual countries negotiate prices with drug companies in accordance with their separate national healthcare systems, members of parliament said the EU can "facilitate dialogue with pharmaceutical companies and promote joint buying of medicines by member states." The "joint buying" point could mark a new front against the pharmaceutical industry in the EU, assuming it gets broader support in the parliament.

The members also plan to hold a specific meeting on "the issue of hepatitis C medicines" in a follow-up meeting in October, the announcement said.

(European Parliament)

How do you Improve the 510(k) Process?

FDA's premarket notification system, also known as the 510(k) process, is something of an accident of history on top of which much of the medical device industry in the US now operates. Rather than having devices be subject to a thorough review of safety and efficacy, the 510(k) process allows devices to be "cleared" into the market by virtue of their substantial equivalence (SE) to an already-approved device (or devices) known as a predicate.

As Jeffery Shapiro of the law firm Hyman Phelps & McNamara argues in a new paper, the process has proven to be a "powerful regulatory tool," with FDA now clearing approximately 98% of all new devices through the pathway.

But a new paper by Shapiro, "Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices," makes another point as well: It's a system in dire need of some improvements.

Shapiro argues for the creation of an "easily searchable" database containing information describing the basis for each 510(k) decision made by FDA.

"The public 510(k) database is clunky and difficult to search. It contains summaries of the 510(k) decisions that are supposed to provide information about the proposed and predicate devices, and the supporting data and conclusions to be drawn from it. However, these summaries are not easily full text searchable," he explains. He also notes that, even when approval summaries are included, they "tend to be deliberately vague about the testing and information submitted to obtain clearance, and they generally reveal little about FDA's review."

"In short, the public is operating from a degraded database as compared to FDA reviewers, who have access to complete 510(k) files, the decision memoranda, and institutional knowledge of their prior decisions," he concludes. "Ultimately, there should be an up-to-date and publicly searchable 510(k) database consisting of all 510(k) files in full text searchable format (including the original submission, relevant correspondence, clearance letter, cleared indications for use, and FDA’s decision memorandum) and available for immediate downloading."

(HPM Paper)

Chocolate-Flavored Cough Syrup? What Could go Wrong…

There's been no shortage of controversy over products containing dextromethorphan in recent years. Several pieces of federal legislation have tried to restrict the medication, which is commonly contained in cough medicines, noting the over-the-counter drug is often abused by teenagers for its hallucinogenic effects when taken in high doses.

Indeed, some states already have in place restrictions on who can purchase the drug, including New Jersey, Nebraska, Alabama and Mississippi.

So it's a bit perplexing to see reports about the introduction of a new dextromethorphan-containing cough medicine that has been re-engineered—not to more abuse-resistant, but to instead taste more like chocolate.

MPR reports that the brand "Dr. Cocoa" has introduced the new version of the drug, featuring "real chocolate taste." While the drug is intended to "improve compliance" in children, the population for which the drug is intended, we can't help but think that a chocolate-flavored drug might also increase rates of abuse. Definitely one to keep an eye on.


Devices Reclassified

FDA has reclassified two medical devices today:

Salivary stimulatory systems, which are being renamed as "electrical salivary stimulator systems" and classified as Class II devices subject to special controls and the premarket notification process.

Tryptase test systems, which will also be subject to Class II special controls and be subject to the market notification process. (Special controls)

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