Tougher FDA import rules are aimed at putting strict controls on imports

Tougher FDA import rules are aimed at putting strict controls on imports 3

Import rules are very rigid and strict in the US, because products of any type and variety can enter the US. The US being the world’s largest consumer economy; manufacturers and marketers from around the world vie for a chunk of this market. The FDA, being the agency that regulates a myriad of products, has rules for imports to the US, which have been toughened of late.

The total number of lines imported to the US more than doubled from 2006, when it was at 15 million lines, to over 35 million in 2016 (The FDA considers a distinct product within a shipment as a line). The FDA’s vigil on products that enter the US and by consumed by Americans is quite understandable: in the fiscal year 2016; among all the imported lines that entered the US; about half consisted of medical devices, and about a third, of foods, both of which are very crucial to human health.

Rules relating to import of drugs
tougherImportRulesForFdaAnother core component of US imports is drugs, which is also extremely crucial to humans. The FDA has very stringent rules for the import of drugs. it does not consider the regulatory approval of any other regulatory agency as acceptable in the US. It considers only regulation of drugs by it as the criterion for accepting imports of drug products. In some cases, however, it relaxes these rules, subject to the condition that the stock of the drug may only be shipped for three months of treatment at a time:

tougherImportRulesForFdaThe FDA has now collaborated with the Customs and Border Patrol Service (CBP), putting even tougher import rules in place. The FDA has not only got tougher in its import rules; it has become even more sophisticated in tracking and detecting importers who violate its rules. New rules require importers to submit many kinds of information and to adhere to set procedures laid out by the government in this regard.

Strict when it comes to penal actions, tooWith the FDA tightening its grip on imports; a foreign manufacturer whose products come under an FDA Import Alert is up against a hill when it comes to importing its products into the U.S. The FDA and the CBP can delay, detain or refuse its shipment or detain a shipment of a company that violates these rules.

The consequences of having a shipment detained 
tougherImportRulesForFdaThe consequences of having a shipment detained by the FDA can bring its adverse consequences:

  • Tougher FDA import rules arm the FDA with the power to begin a potentially long drawn out and expensive legal process
  • It will have very little time to respond to queries from the FDA or the CBP. Not responding in time invites further penalties
  • A fine that is three times the value of the goods contained in the shipment may be imposed
  • At times, their product can be seized ty the government and destroyed
  • If a violating importer receives a release but cannot locate the product that has been sold, it should bring the products back to the port of entry and face adverse legal steps

A few remedial measures 
tougherImportRulesForFdaThe only real antidote to avert profound consequences of the FDA’s tougher import rules is to be aware of the rules in their entirety. A company that has a sound understanding of the legal and prior notice information requirements has a safe passage compared to a company that doesn’t.

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Best Practices in Vendor Risk and Compliance Management

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Best practices in vendor risk and compliance management need to be inculcated by vendors who deal with them because of the enormous risk their activities carry. Implementation of best practices in vendor risk and compliance management goes a long way in checking risks and with it, the adverse fallouts of a vendor management program.

First of all, why do organizations have a vendor partnership? It is because this kind of arrangement helps them to take care of their logistics and other aspects of their business in a much more streamlined and economical fashion, and this in turn helps them to concentrate and focus on their core business better. A strategic vendor partnership helps organizations manage their products and services better, and more economically. The root to this is inculcation of best practices in vendor risk and compliance management.

vendor-risk-and-compliance-managementThe importance of best practices in vendor risk and compliance management can be understood from the fact that when companies outsource their operations, or particular parts of them, or some of their activities, this does not include organizational responsibility. So, the onus of ensuring compliance with regulatory guidelines and making sure that the vendor has implemented best practices in vendor risk and compliance management lies squarely with the organization that outsources.

Burden is on the organization that hires vendorsThis places a heavy responsibility on them, since of late regulatory guidelines for best practices in vendor risk and compliance management have become all the more stringent. While outsourcing part of their activity or operations or logistics or even parts of product development to vendors; companies have to be very sure that they are in tune with best practices in vendor risk and compliance management.

vendor-risk-and-compliance-managementThe basis to implementing best practices in vendor risk and compliance management is to get a clear comprehension of vendor responsibilities. Many organizations make the mistake of assuming that best practices in vendor risk and compliance management need to be implemented only at the stage of selecting the vendor. This is disastrous thinking, because selection of the vendor is just the beginning of the outsourcing program. These organizations have to make sure that best practices in vendor risk and compliance management is a continuous program and activity, and hence utmost care has to go into managing them at all times.

Reasons for increased need for implementation of best practices in vendor risk and compliance managementThe need for adaption and implementation of best practices in vendor risk and compliance management has become all the more acute and necessary in view of the following factors:

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FDA Requirements for ensuring Premarketing Clinical Trial Safety

FDA Requirements for ensuring Premarketing Clinical Trial Safety 2

The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks and benefits that go into the clinical trial, and errors need to be identified and corrected at this stage. Wrong data could lead to disastrous consequences for the study, the subjects that are part of it, the organization and eventually, patients.

Basic nature of FDA requirements for premarketing clinical trial safety

FDA Requirements for ensuring Premarketing Clinical Trial Safety 1

The FDA has a set of requirements for premarketing clinical trial safety, but these are mostly informal and loose. They are more of an advisory nature than being stringent regulatory requirements that are legally enforceable. Most FDA guidance is on a case-by-case nature.

FDA Requirements for ensuring Premarketing Clinical Trial Safety 4

Basically, the FDA’s guidance is based on its working with large to very large clinical trials. It has thus far not seriously considered working with small groups for assessing premarketing clinical trial safety. At its barest, the FDA seeks to:

  • Advise sponsors or organizations undertaking the clinical trial about ways by which their data collection can be simplified so as to ensure that it is neither too huge nor too small, and should lead to giving insights about the drug’s safety. Essentially, the FDA guideline on premarketing clinical trial safety seeks to prevent sponsors from collecting data that is not relevant.
  • Get sponsors to consult the FDA’s review division for its premarketing clinical trial safety.
The FDA has different requirements for different kinds of studies that relate to clinical trials. For example:

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The FDA’s requirements for non-IND Foreign Clinical Studies

The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products

The FDA's requirements for non-IND Foreign Clinical Studies 2

that are permitted under this system of foreign clinical studies include:

  • A human drug
  • A biological drug
  • A medical device

The guidelines for foreign clinical studies requirements

The guidelines under which the FDA accepts medical products for approval when they are the result of foreign clinical studies are spelt out in various sections of 21 CFR.

Any foreign clinical study has to be meet requirements of 21 CFR Part 312or 21 CFR Part 812, which relate to studies conducted under an Investigational New Drug Application (NDA) or Investigational Device Exemption (IDE) respectively, just the same way in which American companies too have to

In case a foreign clinical study is not conducted under an IND; the FDA will still accept it, so long as it fulfills the ethical principles set out in the Declaration of Helsinki, or is in accordance with the laws of the respective country from which the study originates, based on whichever of these two offers stronger protection of the subjects of the study.

Highlights of the Helsinki Declaration

The FDA's requirements for non-IND Foreign Clinical Studies 1

The World Medical Association adapted the Helsinki Declaration from the time it was passed in 1964. In 1975, given the popularity of the Declaration in guaranteeing humane protection of human subjects in a clinical study; the FDA adapted the principles of the Helsinki Declaration as the basis for accepting non-IND compliant drugs. This Declaration has been revised a few times, although the FDA is yet to include the latest of these, that of October 2000, into its regulations.

Points of significance

The Investigational New Drug Applications mechanism in the USA

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The IND is a process which gives the sponsor the opportunity to start marketing across the States of the US without having to complete the formal process. it also gives the patient the assurance that the drug that is being administered may not have gone through the full regulatory process as yet, but is as effective as one that is already in the market. The FDA has three mechanisms in place for submission of an IND.

Present Federal law requires a manufacturer who wants to market a drug in the US to subject the drug to an approved marketing application before it gets transported and/or distributed for interstate commerce, i.e., within the different States in the US.

Since it is very likely that the sponsor of a clinical trial may want to ship the investigational drug to clinical investigators across several states, it is but natural that the sponsor would look for exemption from this legal requirement. The Investigational New Drug (IND) Applications in the USA is the mechanism through which this exemption issues from the FDA to the sponsor.

investigationalNewDrugApplicationsInTheUsaWe can understand the Investigational New Drug Application this way: it is a request made by the sponsor of a clinical study with the FDA asking for its authorization to administer a biological product or an investigational drug to humans before the product goes through interstate shipment. The IND application should also be made before administering a drug that is not the same as an approved New Drug Application or Biologics/Product License Application.

The rationale behind filing Investigational New Drug Application

 

Ensuring a drug’s safety for use in humans is the basis for the entire idea of filing an Investigational New Drug Application. This is the prelude to the steps for its commercialization. By paving the way for further actions such as data collection; the Investigational New Drug Application is often the predecessor step for reinforcing the drug’s safety. An Investigational New Drug Application can be understood or taken as some kind of assurance or guarantee that when the drug that is at this stage of studies is administered on humans; it is not harmful and does not carry risks.

Ensuring a drug’s safety for use in humans is the basis for the entire idea of filing an Investigational New Drug Application. This is the prelude to the steps for its commercialization. By paving the way for further actions such as data collection; the Investigational New Drug Application is often the predecessor step for reinforcing the drug’s safety. An Investigational New Drug Application can be understood or taken as some kind of assurance or guarantee that when the drug that is at this stage of studies is administered on humans; it is not harmful and does not carry risks.

The FDA’s roleinvestigationalNewDrugApplicationsInTheUsaThe FDA’s comes into the picture when the sponsor who files an Investigational New Drug Application wants to test the effect on humans of molecules that it has screened and identified. At this stage, the status of the molecule changes into a new drug that is subject to the requirements set out by the regulatory system.

Kinds of INDsThere are three types of Investigational New Drug Applications:

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Elements of an Investigational New Drug Application
investigationalNewDrugApplicationsInTheUsaThe FDA requires an Investigational New Drug Application to contain the following:

  • Studies carried out for testing animal pharmacology and toxicology
  • Information about the manufacturing aspects of the drug
  • Information about the clinical protocols and investigator of the Investigational New Drug Application

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The increasing role of the social media in healthcare

 

The increasing role of the social media in healthcare 6With the social media having moved beyond being a platform for sharing personal information; its role in healthcare has nearly exploded of late. This is mainly because the growth of the social media has more or less coincided with that of the electronic records in healthcare.

Whatever the identifiable or unidentifiable reasons for the convergence of social media in healthcare; the fact is that social media in healthcare is a major phenomenon that is here to stay.

Social media in healthcare is being analyzed for potentially huge business opportunity, and it is being taken up for serious discussion in legal circles, with the American Congress and many other legislative bodies around the world thinking of taking serious steps for regulating it.

The increasing role of the social media in healthcare 4

The most fundamental aspect of social media in healthcare is that its growth has been helped by the core feature it brings: its ease of adaption in this sector. Healthcare information, as we all know, is very vital, and speed is of great importance. This is why social media in healthcare has come to be one of the most talked about scenarios in the healthcare today, propped in no less measure by the gigantic size of the American healthcare economy.

The advantages social media brings into healthcare

 

The increasing role of the social media in healthcare 1As just seen, the social media in healthcare facilitate great use because they help transmit information at a pace that was difficult to imagine till recently. With the development of the electronic health records (EHR) in the US, technology has made possible the customization of health records. A platform like the social media can help accelerate this pace enormously. It can also help practitioners and other stakeholders of healthcare information, such as Business Associates and Covered Entities and a host of related ones gather information and transmit it and process it at lightning speed.

Concerns

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The enormous benefits that the social media bring into healthcare notwithstanding; there is room for serious concern.

Like all other technology-driven tools, the social media in healthcare comes with an inherent risk: the laxity of records. Loose or nil security or healthcare records are a serious cause for concern. The recent breaches in health data have cost many healthcare organizations in the US millions of dollars.

The social media in healthcare give an opportunity for marketers to pitch their products or services, but they also open up lots of opportunity for the unscrupulous among these to exploit and manipulate this information. This is akin to the potential drawbacks credit cards and other such facilities bring. The social media in healthcare is a tool that is open to a high degree of vulnerability to breach. This is all the more true of new technologies, such as the cloud, which the social media in healthcare have embraced with open arms.

So, while the social media in healthcare is a force to reckon with, it is not something that is totally free of drawbacks. Till regulatory action frees the sector of these, the social media in healthcare will continue to grow, albeit with its concerns.

 

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Technical Writing for the Pharma, Device and Biotech Industries

Technical Writing for the Pharma, Device and Biotech Industries 3

Technical writing for the IT industry is quite different from technical writing for the pharma, device and biotech industries. Technical writing for the pharma, device and biotech industries is a combination of skills and science. On the one hand, it requires extensive knowledge required from these vast and diverse, albeit related industries. On the other, it requires good language skills to present on paper what would otherwise constitute dull and prosaic writing that the common reader would likely find quite obtuse.

Understand the audience

Technical Writing for the Pharma, Device and Biotech Industries

Technical writing for the pharma, device and biotech industries involves first of all, knowing whom the writing is being done for. This is the foremost requirement, because the level of jargon or depth of the subject that goes into technical writing for the pharma, device and biotech industries is directly proportionate to the level of knowledge the audience has of the subject. If the audience is a professional or academic with high credentials, it is necessary to shape the writing to suit them. Likewise, it is advisable to remain simple and effective and rid the writing of its high sounding cant if it is for a lesser audience.

Understand the minds of regulatory bodies

Technical training in the life sciences

A professional doing technical writing for the pharma, device and biotech industries needs to have a grasp of the intricacies that documentation for regulatory bodies expect and require. The FDA, Eudralex, the ISO and other such bodies require their own standards, so it is necessary for those doing technical writing for the pharma, device and biotech industries to be aware of these.

Understand for whom the writing is being done

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Anyone doing technical writing for the pharma, device and biotech industries has to be aware of the market for which the writing is being done. They should understand the role and importance their writing plays with the eventual user. There should be clear understanding of whether technical writing done for the pharma, device and biotech industries is going to be used for higher research, for understanding the market better, or for understanding the competitor, and so on.

Understand the nitty gritty of the industryAlso, when doing technical writing for the pharma, device and biotech industries; the writer has to have a good grasp of the technicalities of the industries. Terms in these industries are filled with many hairsplitting definitions and specifications. The writer doing technical writing for the pharma, device and biotech industries has to be completely aware of the differences between each of these. It is only when these fundamentals among others are grasped that writing becomes successful and effective. The ability to also revise and edit what is written should be built into technical writing skills for the pharma, device and biotech industries.

 

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