Direct-to-consumer marketing is a topic of regular interest to regulators with the US Food and Drug Administration. At various times during the past several years, it has announced studies involving the use of composite scores in DTC advertising, the affect of DTC advertising on healthcare professionals , and corrective advertising resulting from improper DTC marketing. Now it's making some substantial changes to a DTC study first approved in 2011, according to docu...

The US Food and Drug Administration (FDA) seems to be on a major kick against unapproved and misbranded diabetes drug products, according to the most recent batch of Warning Letters released on 23 July 2013. Start of a Crackdown FDA often uses batches of Warning Letters to make an enforcement point against practices it does not favor. Rather than releasing 10 Warning Letters over 10 weeks, it may concentrate them all into a single week in the hopes of making a statement...

In March 2011, the European Commission launched a public consultation on an updated eHealth Action Plan for the period 2012-2020 1 , which had been called upon by the Council Conclusions on Safe and Efficient Healthcare through eHealth of December 2009 2 , and superseded the first plan adopted in 2004. Similarly, the US Food and Drug Administration (FDA) promotes the development of mobile medical apps that provide consumers and healthcare professionals with valuable he...

Earlier this week, the US Food and Drug Administration (FDA) made a quiet but important announcement: Supplies of the drug Doxirubicin Liposomal Injection, a widely used cancer drug that has been experiencing massive shortages since 2011, have been resolved. But with the resolution of that shortage has come something else that has been in short supply in recent months as well: regulatory scrutiny for the drug. Background In late 2011, regulators became aware of mounting...

Australia's Therapeutic Goods Administration (TGA) has opened a consultation on proposed changes to the current regulatory framework for the advertising of therapeutic goods to the general public. The TGA noted that it is not proposing any changes relating to the advertising of prescription and certain pharmacist-only medicines to the general public, which will remain prohibited in Australia. The objectives of the proposed reforms are to: Improve the timeliness and ...

The use of eHealth systems and services-defined as healthcare practice using the Internet-offers great potential to enhance patient safety by avoiding medical errors and improving communications, while reducing costs and inefficiencies in areas such as record keeping. 1 Because of this potential to improve health systems, the use of eHealth technology to aid in medical diagnosis and treatment and support pharmaceutical communication will likely become increasingly commo...

The US Food and Drug Administration (FDA) has issued a rare multi-agency warning letter to a marketer of a product claiming to give patients protection against the influenza virus. The letter, sent on 24 January 2013 to Flu and Cold Defense LLC ('FCD'), was sent in conjunction with the Federal Trade Commission (FTC). Both FDA and FTC regularly work together on matters related to advertising, but the joint warning letter is extraordinarily rare, as FTC ordinarily defers...

In a potentially landmark ruling, the US 2 nd Circuit Court of Appeals has reversed a lower court's finding that a pharmaceutical sales representative was guilty of promoting off-label uses for certain approved drug products, finding that the government's actions had violation the man's right to free speech. Many analysts questioned whether the ruling could eventually lead to a sea change in the way drug promotion is conducted in the US. Currently, companies are not a...

Many promotional materials contain comparative statements that suggest one product is superior to others on the market. These presentations often involve comparisons of the products' efficacy or safety profiles, but they may also compare indications, dosages, patient preferences, price and so on. Use of comparative claims is not without risk, however. In recent years, more than a third of all Warning and Untitled Letters issued by the US Food and Drug Administration's (...

The US Food and Drug Administration (FDA) has sent a warning letter to dietary supplement manufactured Advanced Nutritional Technology (AN) Inc . after regulators said an inspection found deficiencies that caused the products to be adulterated under federal law. AN calls itself an international, specialist manufacturer of all-natural nutritional supplements. FDA's warning letter, sent 16 October 2012 and published on 23 October, largely concerns violations of federal c...

Officials with Abbott Laboratories have announced the suspension of a controversial policy that has stoked controversy with critics who claim the company is buying favors from prescribing physicians by lavishing them with valuable gifts, reports Reuters . In an email obtained by the news organization, Abbott Healthcare, a subsidiary of its North American counterpart, said it would henceforth only distribute approved literature to prescribing physicians. "No brand ...

The US Food and Drug Administration (FDA) has taken aim at another of the cosmetic industry's giants over the use of marketing claims reserved for approved pharmaceutical products-its fourth warning to such a company in the last two months. The agency had previously sent warning letters-advanced notices of intended regulatory action-to L'Oreal subsidiary Lancôme USA , Nevada-based Andes Natural Skin Care and New Jersey-based Janson Beckett , all of which were a...