Posted: 06 Aug 2015 08:38 PM PDT
By Jeffrey K. Shapiro & Jeffrey N. Gibbs –
The Office of Combination Products (OCP) was established in 2002 to improve the agency’s handling of combination products and also drug versus device classification decisions. Unfortunately, it has become clear that more needs to be done. FDA’s approach to these issues continues to slow technological innovation.
Senators Isakson, Casey and Roberts have introduced a reform bill called, “The Combination Product Regulatory Fairness Act of 2015” (S. 1767). This bill is a good start, but more is needed. This post will focus on reform of drug versus device classification decisions.
For certain types of products, it can be a close question whether it is a drug or device under the statute. This area of decision making by the OCP badly needs reform.
As the OCP reads the Food, Drug, and Cosmetic Act (FDCA), any product intended to diagnose, prevent or treat disease, or alter the structure or function of the body is presumptively a drug unless an applicant proves that it satisfies the “device exclusionary clause.” This clause states that an article is a device if it “does not achieve its primary intended purposes through chemical action within or on the body of man … and … is not dependent upon being metabolized for the achievement of its primary intended purposes.” Id., sec. 201(h).
Whether or not the OCP’s reading of the FDCA in this regard is plausible, there are important classes of products historically regulated as devices that have some degree of chemical action. For example, many dermatological products fall in this category. Various washes or skin care products with neutralizing or surfactant properties are another example. Now, when a new product is presented, the OCP requires detailed information – within its 15-page limit – about the chemical action of each and every component and classifies the product as a device if it cannot be proven that the exclusionary clause is satisfied.
This approach leads to inconsistency with historical agency classification decisions, so that a product intended to compete with other devices is forced to undergo much more burdensome drug regulation. OCP’s lack of transparency also means surprises for applicants, since they had expected – and reasonably so – that like products would be regulated in a like manner. Furthermore, for many of these products, the drug regulatory framework is a bad fit and unnecessarily burdensome for the protection of public health. In many instances, the more burdensome drug provisions mean that the company abandons the attempt to sell the product in the U.S.
The Isakson bill would create a procedure requiring the OCP to provide a scientific rationale for its conclusion that chemical action is responsible for achieving a product’s primary intended purpose, and would permit a sponsor the option to propose a study to resolve the issue.
This solution is not likely to yield good fruit. It will not be difficult for the OCP to provide a rationale, even if supported by little science. It often does so now. Once the decision is made, with or without a required scientific rationale, it is difficult or impossible as a practical matter for the sponsor to challenge. An appeal goes to the Office of Special Medical Programs (OSMP), where matters often languish without a decision for well past a year. While OCP must decide in 60 days, OSMP has no deadline. A lawsuit is likely to be prohibitively expensive for most sponsors, and represents even more years of delay.
Sponsors have always had the opportunity to provide study data to show that chemical activity is not responsible for the product’s primary purpose. In our experience, and as shown by the Prevor litigation (see our previous posts here, here, and here), the OCP tends to apply narrow and stringent constructions on the data, with a bias toward concluding that the study does not exclude chemical action as playing a role in product performance. Since the study must prove a negative, i.e., that chemical action doesnot play a role – or at least more than a minor role – it is easy for the OCP to dismiss almost any such study as insufficient.
The more formal opportunity to develop a study in the Isakson bill may make it possible to provide supporting data more efficiently, but is unlikely to resolve the problems identified above. It also places quite a burden on a sponsor, requiring a study solely to address classification, even before undertaking additional studies to show that the product is safe and effective.
At a minimum, the burden of scientific proof should be reversed and placed upon the OCP. That is, instead of the sponsor proving that there is no chemical action involved in achieving the product’s primary purpose, the OCP should not be permitted to classify a product as a drug unless it proves that a product claimed to be a device actually uses chemical (or metabolic) action as the primary mechanism for achieving the product’s primary purpose.
More fundamentally, the problem with the Isakson bill on this point is that it applies a procedural solution to a substantive problem: the OCP’s construction of the governing statute. A root cause solution to the problem does not require a new procedure; it requires a revision to the statute to shift the burden of proof and to require that the chemical or metabolic action be the primary mechanism for achieving the product’s primary purpose.
To be clear, we are not questioning the OCP’s good faith in its classification decisions. The problem is that, as a practical matter, the OCP’s decisions are not yielding good outcomes from a public health perspective, and create confusion by being inconsistent with prior classifications. The solution is to revise the statute to help direct the OCP’s energies in the right direction.
One final, somewhat technical, note: The exclusionary clause in the device definition requires that chemical action not be required to achieve the products “primary purposes.” The Isakson bill refers to the “primary purpose.” This distinction, believe it or not, has been a subject of litigation. The OCP, at least for a time, declared every possible purpose to be “primary” and thereby precluding device classification if any of them were achieved by chemical action. It would be helpful to clarify it by striking the “s” and changing “primary purposes” to “primary purpose.”
Or, even more helpfully, Congress could change “primary purposes” in the exclusionary clause to “intended use” which is the key phrase in the device definition. No one, to our knowledge, has explained the why “intended use” is used in the body of the definition but “primary purposes” is used in the exclusionary clause. This discrepancy seems to serve no purpose other than to stir up confusion.
The Office of Combination Products (OCP) was established in 2002 to improve the agency’s handling of combination products and also drug versus device classification decisions. Unfortunately, it has become clear that more needs to be done. FDA’s approach to these issues continues to slow technological innovation.
Senators Isakson, Casey and Roberts have introduced a reform bill called, “The Combination Product Regulatory Fairness Act of 2015” (S. 1767). This bill is a good start, but more is needed. This post will focus on reform of drug versus device classification decisions.
For certain types of products, it can be a close question whether it is a drug or device under the statute. This area of decision making by the OCP badly needs reform.
As the OCP reads the Food, Drug, and Cosmetic Act (FDCA), any product intended to diagnose, prevent or treat disease, or alter the structure or function of the body is presumptively a drug unless an applicant proves that it satisfies the “device exclusionary clause.” This clause states that an article is a device if it “does not achieve its primary intended purposes through chemical action within or on the body of man … and … is not dependent upon being metabolized for the achievement of its primary intended purposes.” Id., sec. 201(h).
Whether or not the OCP’s reading of the FDCA in this regard is plausible, there are important classes of products historically regulated as devices that have some degree of chemical action. For example, many dermatological products fall in this category. Various washes or skin care products with neutralizing or surfactant properties are another example. Now, when a new product is presented, the OCP requires detailed information – within its 15-page limit – about the chemical action of each and every component and classifies the product as a device if it cannot be proven that the exclusionary clause is satisfied.
This approach leads to inconsistency with historical agency classification decisions, so that a product intended to compete with other devices is forced to undergo much more burdensome drug regulation. OCP’s lack of transparency also means surprises for applicants, since they had expected – and reasonably so – that like products would be regulated in a like manner. Furthermore, for many of these products, the drug regulatory framework is a bad fit and unnecessarily burdensome for the protection of public health. In many instances, the more burdensome drug provisions mean that the company abandons the attempt to sell the product in the U.S.
The Isakson bill would create a procedure requiring the OCP to provide a scientific rationale for its conclusion that chemical action is responsible for achieving a product’s primary intended purpose, and would permit a sponsor the option to propose a study to resolve the issue.
This solution is not likely to yield good fruit. It will not be difficult for the OCP to provide a rationale, even if supported by little science. It often does so now. Once the decision is made, with or without a required scientific rationale, it is difficult or impossible as a practical matter for the sponsor to challenge. An appeal goes to the Office of Special Medical Programs (OSMP), where matters often languish without a decision for well past a year. While OCP must decide in 60 days, OSMP has no deadline. A lawsuit is likely to be prohibitively expensive for most sponsors, and represents even more years of delay.
Sponsors have always had the opportunity to provide study data to show that chemical activity is not responsible for the product’s primary purpose. In our experience, and as shown by the Prevor litigation (see our previous posts here, here, and here), the OCP tends to apply narrow and stringent constructions on the data, with a bias toward concluding that the study does not exclude chemical action as playing a role in product performance. Since the study must prove a negative, i.e., that chemical action doesnot play a role – or at least more than a minor role – it is easy for the OCP to dismiss almost any such study as insufficient.
The more formal opportunity to develop a study in the Isakson bill may make it possible to provide supporting data more efficiently, but is unlikely to resolve the problems identified above. It also places quite a burden on a sponsor, requiring a study solely to address classification, even before undertaking additional studies to show that the product is safe and effective.
At a minimum, the burden of scientific proof should be reversed and placed upon the OCP. That is, instead of the sponsor proving that there is no chemical action involved in achieving the product’s primary purpose, the OCP should not be permitted to classify a product as a drug unless it proves that a product claimed to be a device actually uses chemical (or metabolic) action as the primary mechanism for achieving the product’s primary purpose.
More fundamentally, the problem with the Isakson bill on this point is that it applies a procedural solution to a substantive problem: the OCP’s construction of the governing statute. A root cause solution to the problem does not require a new procedure; it requires a revision to the statute to shift the burden of proof and to require that the chemical or metabolic action be the primary mechanism for achieving the product’s primary purpose.
To be clear, we are not questioning the OCP’s good faith in its classification decisions. The problem is that, as a practical matter, the OCP’s decisions are not yielding good outcomes from a public health perspective, and create confusion by being inconsistent with prior classifications. The solution is to revise the statute to help direct the OCP’s energies in the right direction.
One final, somewhat technical, note: The exclusionary clause in the device definition requires that chemical action not be required to achieve the products “primary purposes.” The Isakson bill refers to the “primary purpose.” This distinction, believe it or not, has been a subject of litigation. The OCP, at least for a time, declared every possible purpose to be “primary” and thereby precluding device classification if any of them were achieved by chemical action. It would be helpful to clarify it by striking the “s” and changing “primary purposes” to “primary purpose.”
Or, even more helpfully, Congress could change “primary purposes” in the exclusionary clause to “intended use” which is the key phrase in the device definition. No one, to our knowledge, has explained the why “intended use” is used in the body of the definition but “primary purposes” is used in the exclusionary clause. This discrepancy seems to serve no purpose other than to stir up confusion.
.png)
No hay comentarios:
Publicar un comentario